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PURPOSE: To evaluate the structural and functional changes in eyes with neovascular age related macular degeneration (nAMD) in a real-world setting, using Treat and Extend protocol (T&E), comparing four antiangiogenic agents. METHODS: Prospective, observational, case series study performed in 131 patients with the exudative form of nAMD. Patients were randomly assigned into four groups according to the antiangiogenic agent. During the first year, all eyes received at least 3 monthly intravitreal injections of antiangiogenic agents, and afterwards, were submitted to the T&E. RESULTS: There was statistically significant difference (p < 0.05) between pre- and post-treatment in the best corrected visual acuity measurements by drug used. Patients who used aflibercept had significantly fewer injections than patients using the other drugs (mean = 9.03). No significant difference was observed between the drugs bevacizumab, ranibizumab and ziv-aflibercept. With regard to biomarkers, patients who used aflibercept and had lower baseline central retinal thickness, absence of hyperreflective foci and no subretinal hyperreflective material had the lowest number of injections. CONCLUSION: Results indicate that over 2 years, Intravitreal aflibercept on T&E provided better visual and anatomical improvements when compared to other drugs used in this study with significantly fewer injections.

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Management of vitreoretinal disorders (e.g., neovascular age-related macular degeneration [nAMD] and diabetic macular edema [DME]) have assumed the standard therapy of lifelong anti-VEGF injections with drugs like aflibercept, brolucizumab, ranibizumab and bevacizumab. However, the burden imposed on patients is a major deterrent for continual therapy and recovery. Faricimab, a bispecific antibody, blocking both VEGF-A and Ang-2 molecules, produces a comparable functional and anatomical results, with less injections, significantly reducing patient burden. Visual acuity, safety, adverse effects, and anatomical outcomes are discussed in the pivotal clinical trials (YOSEMITE/RHINE and TENAYA/LUCERNE), and early data from real-world studies (TRUCKEE, TAHOE, FARWIDE-DME, FARETINA and others). In YOSEMITE and RHINE, faricimab demonstrated non-inferior vision gains, better anatomical outcomes compared to aflibercept every 8 weeks. Faricimab in the personalized treatment interval (PTI), after week 96, achieved 12-week interval in 78.1% of the patients and 16-week interval in 62.3%. TENAYA and LUCERNE reported comparable best corrected visual acuity (BCVA) improvement and better anatomic outcomes during head-to-head phase, parallel to aflibercept, at its 8-week treatment schedule. Faricimab in the PTI regimen, after week 96 achieved 12-week interval in 77.8% of the patients and 16-week interval in 63.1%. Safety of faricimab has been comparable to aflibercept in these pivotal trials. Real-world data supports the data from the pivotal studies regarding the efficacy and safety profile of faricimab in heterogenous real world patient population. Moreover, in previously treated patients, it also demonstrated a faster fluid resolution, good safety profile. Considering faricimab has demonstrated anatomic and durability benefit in the treatment of nAMD and DME, additional data from ongoing extension clinical trials, AVONELLE-X and RHONE-X will help understand longer term outcomes for patients treated with faricimab as well as patients switching from aflibercept to faricimab after finishing the pivotal trials. Longer term data from the real-world studies will also continue to contribute to our understanding of long-term efficacy, safety and durability in the real world patient population.

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Anti-VEGF drugs like ranibizumab can be used to treat retinopathy of prematurity (ROP) by halting the formation of abnormal blood vessels, or lasers can be used to burn the edges of the retina where these vessels are present. The objective is to compare the efficacy for ROP between ranibizumab and laser therapy. Material and methods: Electronic searches will be carried out in medical databases with key words and controlled vocabulary terms. Randomized controlled trials (RCT) will be assessed. The primary outcome will be the full ROP regression. Two reviewers will extract the data using predefined forms and, to assess the quality of the study, we will use RoB 2.0, the tool for randomized controlled trials developed by the Cochrane Collaboration. We used a combination of the inverse-variance approach and random-effects models for the meta-analysis. Results: The eyes of 182 preterm infants who had ranibizumab treatment were assessed in a total of 364 eyes, and 135 infants received laser therapy. The follow-up period was between 6 and 24 months. Ranibizumab was not associated with greater regression of ROP compared to laser therapy in preterm infants (RR: 1.09, CI 95%: 0.95-1.24; p: 0.22). Also, ranibizumab was not associated with recurrence of ROP compared to laser therapy in preterm infants (RR: 3.77, CI 95%: 0.55-25.81; p: 0.22). Conclusions: The efficacy of ranibizumab compared to laser is very uncertain in terms of ROP regression and decreased ROP recurrence in preterm infants. Systematic Review Registration: identifier PROSPERO (CRD42022324150).

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Introducción: La retinopatía del prematuro es una enfermedad ocular provocada por una alteración en la vasculogénesis de la retina, que lleva a la pérdida parcial o total de la visión. Objetivo: Presentar el primer caso, en la provincia de Santa Clara, de retinopatía de la prematuridad agresiva posterior y el tratamiento realizado. Presentación del caso: Niña prematura con más de 5 factores de riesgo al nacer que presentó retinopatía de la prematuridad agresiva posterior y se le realizó tratamiento con bevacizumab intravítreo. Conclusiones: La evolución de la niña en un período de un 1 año resultó satisfactoria con regresión total de la enfermedad. El tratamiento establecido constituye un método alternativo con buenos resultados en algunas condiciones específicas como la retinopatía del prematuro agresiva posterior(AU)

Introduction: Retinopathy of prematurity is an ocular disease caused by an alteration in retinal vasculogenesis, leading to partial or total loss of sight. Objective: To present the first case, in the province of Santa Clara, of aggressive posterior retinopathy of prematurity and the treatment performed. Case presentation: Premature girl with more than 5 risk factors at birth who presented aggressive posterior retinopathy of prematurity and was treated with intravitreal bevacizumab. Conclusions: The evolution of the girl in a period of 1 year was satisfactory with total regression of the disease. The established treatment constitutes an alternative method with good results in some specific conditions such as aggressive posterior retinopathy of prematurity(AU)

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BACKGROUND: Biomarkers hold great promise for personalized medicine as information gained from diagnostic or progression markers can be used to tailor treatment to the individual for highly effective intervention in the disease process. METHODS: The aim of this retrospective study was to evaluate the association between visual outcome and the presence of findings of uncertain significance by optical coherence tomography (OCT) pre and post loading dose in patients with neovascular age-related macular degeneration (nAMD) treated with ranibizumab. RESULTS: Univariate analysis revealed a higher letter gain in those with presence of onion sign (+ 5.6 ETDRS letters, p = 0.04) absence of prechoroidal cleft (+ 3.7 ETDRS letters, p = 0.04), intraretinal pseudocysts (+4.8 ETDRS letters, p = 0.002), subretinal pseudocysts (+ 4.6 ETDRS letters, p = 0.005) and choroidal caverns (+ 4.4 ETDRS, letters p = 0.0065). CONCLUSIONS: The presence of prechoroidal cleft, intraretinal and subretinal pseudocysts and choroidal caverns were associated with lower visual gains. Moreover, we found that the onion sign is related as a biomarker of good prognostics. Trial registration Registration number: 2021R13B2. Date of registration: 01/05/2020.

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ABSTRACT Purpose: To evaluate contrast sensitivity in non-high-risk, treatment-naïve proliferative diabetic retinopathy patients treated with panretinal photocoagulation and intravitreal injections of ranibizumab) versus panretinal photocoagulation alone. Methods: Sixty eyes of 30 patients with bilateral proliferative diabetic retinopathy were randomized into two groups: one received panretinal photocoagulation and ranibizumab injections (study group), while the other received panretinal photocoagulation alone (control group). All eyes were treated with panretinal photocoagulation in three sessions according to the Early Treatment Diabetic Retinopathy Study guidelines. Contrast sensitivity measurements were performed under photopic conditions (85 cd/m2) with the Visual Contrast Test Sensitivity 6500 chart, allowing for the evaluation of five spatial frequencies with sine wave grating charts: 1.5, 3.0, 6.0, 12.0, and 18.0 cycles per degree (cpd). Outcomes were measured in contrast sensitivity threshold scores among and within groups, from baseline to 1, 3, and 6 months. Results: Fifty-eight eyes (28 in the study group and 30 in the control group) reached the study endpoint. A comparative analysis of changes in contrast sensitivity between the groups showed significant differences mainly in low frequencies as follows: at month 1 in 1.5 cpd (p=0.001) and 3.0 cpd (p=0.04); at month 3 in 1.5 cpd (p=0.016), and at month 6 in 1.5 cpd (p=0.001) and 3.0 cpd (p=0.026) in favor of the study group. Conclusions: In eyes of patients with non-high-risk proliferative diabetic retinopathy, panretinal photocoagulation treatment with ranibizumab appears to cause less damage to contrast sensitivity compared with panretinal photocoagulation treatment alone. Thus, our evaluation of contrast sensitivity may support the use of ranabizumab as an adjuvant to panretinal photocoagulation for the treatment of proliferative diabetic retinopathy.

RESUMO Objetivos: Avaliar a sensibilidade ao contraste em pacientes virgens de tratamento com retinopatia diabética proliferativa de não alto risco, submetidos a panfotocoagulação retiniana com injeções intravítreas de ranibizumabe versus pan­fotocoagulação isolada. Métodos: Sessenta olhos de 30 pa­cientes foram randomizados em dois grupos: um submetido a panfotocoagulação com injeções de ranibizumabe (grupo estudo), e o outro submetimedo a panfotocoagulação isolada (grupo controle). Todos olhos foram tratados em 3 sessões de laser, seguindo recomendação do Early Treatment Diabetic Retinopathy Study (ETDRS). Avaliação da sensibilidade ao contraste foi realizada sob condições fotópicas (85 cd/m2) com tabela Visual Contrast Test Sensitivity 6500, permitindo avaliação de cinco frequências espaciais medidas com redes senoidais: 1.5, 3.0, 6.0, 12.0 e 18.0 ciclos por grau de ângulo visual (cpd). Foram realizadas medidas dos limiares de sensibilidade ao contraste intra e entre grupos na visita inicial, no 1º, 3º, e 6º mês de seguimento. Resultados: Cinquenta e oito olhos, 28 do grupo estudo e 30 do grupo controle, atingiram o término do estudo. Análise comparativa da SC entre os grupos mostrou diferença estatisticamente significante, nas baixas frequências espaciais, no 1º mês em 1.5 cpd (p=0,001) e 3.0 cpd (p=0,04), no 3º mês em 1.5 cpd (p=0,016) e no 6º mês em 3.0 cpd (p=0,026) a favor do grupo estudo. Conclusão: O tratamento com panfotocoagulação associada a injeção de ranibizumabe parece causar menos danos a sensibilidade ao contraste quando comparada com panfotocoagulação isolada em olhos com retinopatia diabética proliferativa de não alto risco. Dessa forma, os resultados apresentados podem justificar a associação do ranibizumabe à panfotocoagulação nestes pacientes.

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PURPOSE: The purpose of this study was to report the 5-year outcomes of treatment-naive eyes with cystoid macular edema secondary to central retinal vein occlusion treated with intravitreal bevacizumab in routine clinical practice. METHODS: We conducted multicenter retrospective non-comparative case series of 102 eyes. The main outcome measured was the change in best-corrected visual acuity (BCVA) at 5 years. Secondary outcomes included the number of injections and the change in CMT at 5 years. RESULTS: At 5 years, the mean BCVA improved from 1.22 ± 0.58 (Snellen 20/428) at baseline to 1.00 ± 0.68 logMAR (Snellen 20/200; p < 0.0001). At 5 years, 48 (47%) eyes had a gain of ≥ 3 lines, 41 (40.2%) eyes remained within 3 lines and 13 (12.7%) eyes had a loss of ≥ 3 lines of BCVA. The CMT improved from 740 ± 243 to 322 ± 179 µm (p < 0.0001). At 5 years, 59 (57.8%) eyes had a completely dry SD-OCT. Patients received a total of 10.6 ± 6.1 (range 6-27) injections. Baseline BCVA (p < 0.0001) and the duration of symptoms prior to initial anti-VEGF injection (p = 0.0274) were the only predictive factors for BCVA at 5 years. CONCLUSIONS: After 5 years with an average of 10.6 injections, there was a mean gain of 0.22 logMAR. In addition, more eyes achieved a BCVA of ≥ 20/40, gained ≥ 3 lines and less patients had a BCVA ≤ 20/200. Eyes with a better baseline BCVA and a shorter duration of symptoms were more likely to achieve better BCVA at 5 years.

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Novel strategies have been developed to reduce or avoid intravitreal injections (IVTs) of the antiangiogenic (ranibizumab (RBZ)) and anti-inflammatory (triamcinolone acetonide (TA)) agents used to treat vitreoretinal diseases. One of the strategies includes liposomes. This study evaluated the safety and efficacy of a topical triamcinolone-loaded liposome formulation (TALF) as an adjuvant to intravitreal RBZ therapy in treatment- naïve patients with neovascular age-related macular degeneration (nAMD). Subjects were randomly assigned to the RBZ-TALF or the RBZ-pro re nata (RBZ-PRN) groups. Patients from the RBZ-TALF group were instructed to apply TALF for 12 months after a single dose of RBZ. Patients from the RBZ-PRN group received three monthly RBZ-IVTs. Retreatment with RBZ was considered in the case of nAMD reactivation. Regarding safety, non-ocular abnormalities were observed during TALF therapy. Concerning efficacy, non-significant differences were identified in terms of visual acuity or central foveal thickness when the RBZ-PRN and RBZ-TALF groups were compared. It is worth noting that the average number of RBZ injections was significantly lower in the RBZ-TALF group (2.5 ± 1.4 vs. 6.1 ± 1.3 IVTs; p = 0.0004). Therefore, TALF used as an adjuvant to RBZ reduces the need for RBZ-IVT retreatment with optimal visual and anatomic results.

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PURPOSE: To compare ETDRS panretinal laser photocoagulation (PRP) combined with intravitreal injection of ranibizumab (IVR) and photocoagulation targeted to ischemic retina (PIR) combined with IVR in patients with proliferative diabetic retinopathy (PDR). METHODS: PDR patients were randomly assigned to treatment with either PRP + IVR or PIR + IVR. ETRDS Best-corrected visual acuity (BCVA) and central subfield thickness (CSFT) measured on optic-coherence tomography images (OCT-Heidelberg Spectralis) were recorded at baseline and every 4 weeks for one year. Fluorescein leakage area (FLA) from active new vessels was measured every 12 weeks. Full-field ERG was recorded by means of DTL electrodes, following ISCEV standard recommendations, at baseline and after 3 months. RESULTS: Twenty-eight eyes completed the study period. At baseline, mean ± SE BCVA (logMAR) was 0.44 ± 0.07 and 0.37 ± 0.08 (P = 0.5030); CSFT (µm) was 324.0 ± 20.4 and 330.1 ± 22.1 (P = 0.8417); and FLA (mm2) was 16.10 ± 4.42 and 9.97 ± 1.83 (P = 0.2114) for PRP + IVR and PIR + IVR groups, respectively. There were no relevant changes on BCVA or CSFT, but a significant reduction for FLA was observed at all visits compared to baseline for both groups, with no differences between groups. ERG showed at baseline reduced dark-adapted amplitudes, and these changes were also significantly amplified after laser treatment. ROD b-wave amplitude was further reduced in 62 ± 6% for PRP + IVR and 59 ± 4% for group PIR + IVR, but with no between-groups significant difference (P = 0.9082). CONCLUSIONS: PIR + IVR or PRP + IVR are comparable strategies regarding FLA control in PDR and led to similar retinal function impairment, based on ERG changes up to one-year follow-up. TRIAL REGISTRATION NUMBER: NCT03904056, date of registration 02/11/2019, retrospectively registered.

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ABSTRACT We conducted retinal neovascularization under subfoveal fibrotic nodule for Coats disease by using optic coherence tomography-angiography before and after ranibizumab treatment. Our patient was an 8-year-old boy who was referred with suspicious left retinal mass. His visual acuity was 20/400 in the left eye and 20/20 in the right eye at the time of admission. Posterior segment evaluation of the left eye revealed telengiectatic vessels at the inferotemporal region of the peripheral retina with hard exudates around the optic disc and macula typical for Coats disease. His optic coherence tomography revealed a subfoveal fibrotic nodule after ranibizumab injections and laser photocoagulation treatment. The optic coherence tomography-angiography results revealed neovascularization under the subfoveal nodule at the superficial vascular complex layer. After 3 intravitreal ranibizumab injections, his neovascularization regressed on optic coherence tomography-angiography and his visual acuity improved. To the best of our knowledge, this is the first report demonstrating neovascularization under the subfoveal fibrotic nodule in Coats disease on the basis of comparative with the help of optic coherence tomography-angiography before and after the treatment.

RESUMO Demonstramos uma neovascularização da retina sob o nódulo fibrótico subfoveal na doença de Coats com a ajuda da Angiotomografia de Coerência Óptica (OCT-A) antes e após o tratamento com ranibizumabe. Paciente do sexo masculino de 8 anos foi encaminhado com suspeita de massa retiniana no olho esquerdo. A acuidade visual foi de 20/400 no olho esquerdo e de 20/20 no olho direito. A avaliação do segmento posterior do olho esquerdo revelou vasos telengiectáticos na região inferotemporal da retina periférica e exsudados duros em torno do disco óptico e mácula típica da doença de Coats. A angiotomografia de coerência óptica apresentou nódulo fibrótico subfoveal após injeções de ranibizumabe e tratamento com fotocoagulação a laser. A angiotomografia de coerência óptica mostrou neovascularização sob o nódulo subfoveal na camada superficial do complexo vascular. Após três injeções de ranibizumabe intravítreo, a neovascularização regrediu na angiografia por tomografia de coerência óptica e a acuidade visual melhorou. onde sabemos, este é o primeiro relato a mostrar neovascularização sob nódulo fibrótico subfoveal na Doença de Coats com a ajuda da angiografia por tomografia de coerência óptica antes e após o tratamento.

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ABSTRACT Purpose: This study was conducted to evaluate visual function and changes in the central macular thickness of patients with unresponsive neovascular age-related macular degeneration who were switched from ranibizumab (Lucentis®) to aflibercept (Eylea®) treatment at 30 months. Methods: This retrospective study examined patients with neovascular age-related macular degeneration who were switched to aflibercept after ≥6 previous intravitreal ranibizumab injections at 4- to 8-week intervals. All patients were switched to intravitreal aflibercept (2.0 mg) and analyzed after 3 consecutive injections followed by a prore nata dosing regimen and after 30 months of treatment. Best corrected visual acuity, biomicroscopic examination, intraocular pressure, fundus examination, and central macular thickness were recorded at the start of treatment, before the transition to intravitreal aflibercept treatment, and at 6, 12, 18, 24, and 30 months of intravitreal aflibercept treatment. Results: A total of 33 eyes met the inclusion criteria. The median age of the patients was 73.57 ± 7.98 years, and 21 (61.8%) patients were males and 12 (35.3%) were females. Before the transition, the patients received a mean of 16.8 ± 8.8 ranibizumab injections (range 6-38).After the transition to intravitreal aflibercept treatment, the mean number of aflibercept injections was 9.09 ± 3.94. No significant differences were observed in best corrected visual acuity after the aflibercept switch in any of the months. The central macular thickness was significantly decreased at 6, 12, 18, and 30 months (p=0.01, p=0.03, p=0.05, p=0.05, p<0.001, respectively). Conclusion: Patients with neovascular age-related macular degeneration who were switched to intravitreal aflibercept treatment due to unresponsiveness to intravitreal ranibizumab exhibited a significant anatomic improvement in the retina, and although this state persisted, there was no significant functional gain.(AU)

RESUMO Objetivo: Avaliar, depois de 30 meses, a função visual e as alterações na espessura macular central de pacientes com degeneração macular relacionada à idade sem resposta terapêutica ao ranibizumabe (Lucentis®) que mudaram seu tratamento para o aflibercepte (Eylea®). Métodos: Realizou-se um estudo retrospectivo de pacientes com degeneração macular neovascular relacionada à idade que mudaram o tratamento para o aflibercepte após 6 ou mais injeções intravítreas de ranibizumabe a intervalos de 4-8 semanas. Todos os pacientes mudaram para o aflibercepte intravítreo (2,0 mg) e depois de 3 injeções consecutivas, seguidas de um regime de dosagem pro re nata, foram avaliados após 30 meses de tratamento. A melhor acuidade visual corrigida, o exame biomicroscópico, a pressão intraocular, a fundoscopia e a espessura macular central foram registrados no início do tratamento, antes da transição para o tratamento com aflibercepte intravítreo e aos 6, 12, 18, 24 e 30 meses de tratamento com o aflibercepte intravítreo. Resultados: Satisfizeram aos critérios de inclusão 33 olhos. A mediana da idade dos pacientes foi de 73,57 ± 7,98 anos. Dos pacientes, 21 (61,8%) eram homens e 12 (35,3%) eram mulheres. Antes da transição para o tratamento com o aflibercepte intravítreo, os pacientes receberam em média 16,8 ± 8,8 injeções de ranibizumabe (faixa 6-38).Depois da transição, o número médio de injeções de aflibercepte foi de 9,09 ± 3,94. Não houve diferenças significativas na melhor acuidade visual corrigida depois da mudança para o aflibercepte em qualquer das avaliações. Houve diminuição significativa da espessura macular central aos 6, 12, 18 e 30 meses (respectivamente, p=0,01, p=0,03, p=0,05, p=0,05 e p<0,001). Conclusão: Pacientes com degeneração macular neovascular relacionada à idade que mudaram seu tratamento para o aflibercepte intravítreo devido à falta de resposta ao ranibizumabe intravítreo, tiveram melhora anatômica significativa da retina; mas embora esse estado tenha persistido, não foi observado nenhum ganho funcional significativo.(AU)

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ABSTRACT Purpose: To compare visual acuity, macular thickness, and the area of active neovascularization based on fluorescein angiography outcomes associated with standard single-spot panretinal photocoagulation in the Early Treatment Diabetic Retinopathy Study (ETDRS) pattern combined with intravitreal ranibizumab injection versus multiple-spot full scatter (PASCAL) panretinal photocoagulation combined with intravitreal ranibizumab injection versus intravitreal injection alone in patients with proliferative diabetic retinopathy. Methods: Patients with proliferative diabetic retinopathy and no prior laser treatment were randomly assigned to receive three different types of treatment. Panretinal photocoagulation in the ETDRS group was administered in two sessions (weeks 0 and 2), and panretinal photocoagulation in the PASCAL group was administered in one session (week 0). Intravitreal injection of ranibizumab was administered at the end of the first laser session in both the ETDRS and PASCAL groups and at week 0 in the intravitreal injection group. Comprehensive ophthalmic evaluations were performed at baseline and every 4 weeks through week 48. Results: Thirty patients (n=40 eyes) completed the 48-week study period. After treatment, best-corrected visual acuity was significantly (p<0.05) improved at all follow-up visits in the group receiving intravitreal injection alone, at all but week 4 in the ETDRS group, and at all but weeks 4 and 8 for the PASCAL group. A significant decrease in central subfield macular thickness was observed in the PASCAL group at weeks 4, 8, and 48; only at week 48 in the intravitreal injection group; and never in the ETDRS group. There was no significant difference among the three treatment groups with respect to change from baseline to week 48 in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization in best-corrected visual acuity, central subfield macular thickness, or fluorescein leakage from active neovascularization. Conclusions: Intravitreal injection alone or combined with single- or multiple-spot panretinal photocoagulation yielded similar outcomes with respect to mean change in best-corrected visual acuity, central subfield macular thickness, and fluorescein leakage from active neovascularization at up to one-year of follow-up. All subjects provided written informed consent to participate (NCT02005432 in clinicaltrials.gov).

RESUMO Objetivo: Comparar as medidas de acuidade visual, espessura macular central e área de neovasos ativos na an­giofluoresceinografia submetidos a panfotocoagulação retiniana padrão ETDRS associado a injeção intravítrea de ranibizumabe versus panfotocoagulação padrão PASCAL associado a injeção intravítrea de ranibizumabe versus somente injeção intravítrea de ranibizumabe em pacientes com retinopatia diabética pro­liferativa. Métodos: Pacientes com retinopatia diabética proliferativa e virgens de tratamento, randomicamente divididos nas três diferentes terapias retinianas. Panfotocoagulação no grupo ETDRS em 2 sessões (semanas 0 e 2) e no grupo PASCAL, na semana 0. Injeção intravítrea de ranibizumabe realizado ao fim da primeira sessão de laser em ambos os grupos: ETDRS e PASCAL, e na semana 0 no grupo injeção intravítrea de ranibizumabe. Avaliações oftalmológicas, tomografia de coerência óptica e angiofluoesceinografia realizados na visita basal e a cada 4 semanas por 48 semanas. Resultados: Trinta pacientes (n=40 olhos) completaram as 48 semanas de seguimento. Após o tratamento, a acuidade visual melhorou significantemente em todas a visitas no grupo injeção intravítrea de ranibizumabe (p<0,05); em todas exceto na semana 4 no grupo ETDRS, em todas exceto nas semanas 4 e 8 no grupo PASCAL. Redução significativa na espessura do subcampo central foi evidenciada no grupo PASCAL nas semanas 4, 8 e 48; somente na semana 48 no grupo injeção intravítrea de ranibizumabe, e em nenhuma visita no grupo ETDRS. Redução também na área de neovasos ativos em todas as visitas em todos os grupos. Não houve diferença significante entre os três grupos com relação a mudança media na medidas de acuidade visual, espessura macular central ou área de neovasos ativos da visita inicial para a semana 48. Conclusões: Somente IVB ou este associado a panfotocoagulação ETDRS ou PASCAL, apresentaram efeitos semelhantes em relação a medidas de acuidade visual, espessura do subcampo central e área de neovasos ativos no decorrer de 48 semanas de seguimento.

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BACKGROUND: In 2020 Colombia may expect to have close to 231,700 patients with neovascular age-related macular degeneration (ARMD). Treatment of neovascular ARMD involves the sequential Intra-vitreal injections of anti-vascular endothelial growth factor (anti-VEGF therapy) medications. The efficacy and safety of anti-VEGF therapy on a treat-and-extend (T&E) dosing scheme are similar when ranibizumab or aflibercept are administered. Objective : A cost-minimization analysis from the payer`s perspective in Colombia projects treatment expenses of anti-VEGF therapy using aflibercept or ranibizumab on T&E regimens for the treatment of neovascular ARMD. Methods : A model projects the expenses of the compared treatment regimens for two and five-year periods beginning on February 2020. The model used information from clinical trials, case series and meta-analyses on the compared treatment regimens, demographic, epidemiologic and economic data originated from the Colombian government sources. A 3% discount rate was applied. Results : Projected cost differences in favor of ranibizumab after two and five-year treatment periods beginning February 2020 could be close to U.S. $ 4,861 and U.S $ 7,241 per treated eye, respectively. If all patients with unilateral and bilateral neovascular ARMD in Colombia were to receive appropriate anti-VEGF therapy for two years, the projected expected cost difference in favor of ranibizumab could be close to U.S. $ 462,717,092 dollars. Conclusion : Within the Colombian healthcare setting anti-VEGF therapy on a T&E regimen utilizing ranibizumab for neovascular ARMD may be cost-saving compared with employing aflibercept. Despite cost favorability, ranibizumab should not be the only therapeutic option since in clinical practice alternatives are required.

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ABSTRACT Purpose: This survey aimed at assessing the clinical characteristics of patients with inflammatory reactions after intravitreal injection of antiangiogenic agents and the techniques employed by Brazilian retina specialists. Methods: We sent an 18-item questionnaire electronically to retina specialists who are using antiangiogenic agents. We got the responses between September 21 and December 23, 2018. Results: A total of 58 retina specialists participated. Most of them were from Southeastern Brazil (50%), 82.8% were dedicated to both medical and surgical practices, and 86.2% had practiced for more than 5 years. Respondents reported a mean number of 2.14 ± 1.63 patients with inflammation, 44.8% with panuveitis, and 79.3% with onset of symptoms within 72 h. Specialists used aflibercept (53.4%), bevacizumab (29.3%), and ranibizumab (27.6%). Most patients were treated with steroid drops (70.7%), and their inflammation subsided after 11.5 ± 11.5 days (86.2% lacked irreversible complications). The specialists blamed the syringe as the cause of the inflammation in 25.9% of the cases, 41.4% used Becton-Dickinson Ultra-Fine syringes, 43.1% injected the drug at room temperature, and 37.9% removed the air (53.4% by flicking the syringe). Most specialists did not detect silicone oil (67.2%), but 17.2% of them performed vitrectomies to remove vitreous opacities. Finally, 44.8% of specialists injected the same antiangiogenic agent in an eye with prior inflammatory reaction without further inflammation. Conclusions: Most specialists reported cases of early-onset inflammation after intravitreal injection of antiangiogenic agents. The incidence of irreversible complications was low. Aflibercept was the most common agent used. The causes of inflammation remain unknown, but we formulated some relevant hypotheses.

RESUMO Objetivo: Esta pesquisa teve como objetivo avaliar as características clínicas de pacientes com reações inflamatórias após injeção intravítrea de agentes antiangiogênicos e as técnicas empregadas por especialistas em retina brasileiros. Métodos: Enviamos eletronicamente um questionário de 18 itens para especialistas em retina que usam agentes antiangiogênicos. Recebemos as respostas entre 21 de setembro e 23 de dezembro de 2018. Resultados: Um total de 58 especialistas em retina participaram. A maioria era do Sudeste do Brasil (50%), 82,8% eram dedicados a práticas médicas e cirúrgicas e 86,2% praticavam há mais de 5 anos. Os entrevistados informaram um número médio de 2,14 ± 1,63 pacientes com inflamação, 44,8% com panuveíte e 79,3% com início dos sintomas dentro de 72 horas. Especialistas utilizaram aflibercepte (53,4%), bevacizumabe (29,3%) e ranibizumabe (26=7,6%). A maioria dos pacientes foi tratada com colírios de esteroides (70,7%), e sua inflamação diminuiu após 11,5 ± 11,5 dias (86,2% não apresentaram complicações irreversíveis). Os especialistas responsabilizaram a seringa como causa da inflamação em 25,9% dos casos, 41,4% usaram seringas Becton-Dickinson Ultra-Fine, 43,1% injetaram a droga em temperatura ambiente e 37,9% removeram o ar (53,4% sacudindo a seringa). A maioria dos especialistas não detectou óleo de silicone (67,2%), mas 17,2% realizaram vitrectomias para remoção de opacidades vítreas. Finalmente, 44,8% dos especialistas injetaram o mesmo agente angiogênicos em um olho com reação inflamatória prévia, sem surgimento de nova inflamação. Conclusões: A maioria dos especialistas relatou casos de inflamação de início precoce após injeção intravítrea de agentes antiangiogênicos. A incidência complicações irreversíveis foi baixa. Aflibercepte foi o agente mais frequentemente usado. As causas da inflamação permanecem desconhecidas, embora formulamos algumas hipóteses relevantes.

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BACKGROUND: To evaluate the change in best corrected visual acuity (VA) and central macular thickness (CMT) following treatment with intravitreal aflibercept (AFL) in patients poorly responders or non responders to ranibizumab (RBZ). METHODS: Charts of patients injected with RBZ from January 2016 to December 2018 (548 cases) due to neovascular age-related macular degeneration (nAMD) were reviewed. Fifty-six cases met our criteria for poor responders to RBZ (CMT decreased between 5 and 15% over treatment) or for non responders to RBZ (CMT decreased less than 5% or increased over treatment). RESULTS: After the third AFL injection, CMT decreased from 384.38 ± 123.20 µm to 296.18 ± 70.52 µm in the non-responder group and from 320.00 ± 82.05 µm to 282.27 ± 56.86 µm in the poor responder group. Although decrease in macular thickness was overall achieved 3 months after switching to AFL, it was not translated in VA improvement. CONCLUSIONS: it was observed that nAMD patients classified as RBZ non-responders tend to respond better to AFL than RBZ poor-responders anatomically, without correspondent improvement in VA.

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Retinal vein occlusion (RVO) is one of the most prevalent causes of visual loss in the Western World. Its pathogenesis is still not completely known. Chronic macular edema and ischemia compromise the functional and anatomical status of the retina. Antivascular endothelial growth factor (anti-VEGF) injections have demonstrated better results than other previous options, including observation or laser therapy. This narrative review aims to analyze the current aspects related to these drugs.

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INTRODUCTION: Macular hemorrhages result in a sudden and profound loss of vision. The primary treatment modalities include observation, intravitreal injection of antiangiogenic drugs, neodymium-doped yttrium aluminum garnet hialoidotomy, intravitreal injection of gas with or without tissue plasminogen activator, as monotherapy or combined with surgery. In this paper, we report four cases of macular hemorrhages of different causes treated with different approaches, and we review the literature in this regard. CASE PRESENTATION: All four patients presented different causes of macular hemorrhage. The first case had a preretinal hemorrhage due to a Valsalva retinopathy and was treated with surgery. Case 2 had a multilevel macular hemorrhage due to a rupture of a retinal arteriolar macroaneurysm and was treated with pneumatic displacement, laser, and intravitreal ranibizumab. Case 3 presented an extensive subretinal hemorrhage due to a choroidal rupture after high-energy ocular trauma that was also successfully treated with surgery. The last case was a preretinal hemorrhage due to diabetic retinopathy managed with neodymium-doped yttrium aluminum garnet laser. Different treatment approaches were successfully performed in all cases with good outcomes. CONCLUSION: There is an extensive range of options available for the management of macular hemorrhages, and the best option depends on the characteristics of each particular case. Proper and timely management of these diseases can achieve an excellent visual outcome, especially if the location of the hemorrhage is preretinal.

INTRODUCCIÓN: Las hemorragias maculares producen una pérdida de la visión súbita y profunda. Las principales modalidades de tratamiento incluyen observación, inyección intravítrea de fármacos antiangiogénicos, hialoidotomía con láser neodymium-doped yttrium aluminium garnet, inyección intravítrea de gas y/o activador de plasminógeno tisular, en monoterapia o combinadas con cirugía. En el presente trabajo reportamos cuatro casos de hemorragias maculares de distintas causas, tratadas con diferentes abordajes, y realizamos una revisión de la literatura al respecto. PRESENTACIÓN DE CASOS: Los cuatro pacientes mostrados presentaron diferentes causas de hemorragias maculares. El primer caso tuvo una hemorragia prerretiniana debido a retinopatía de Valsalva y fue tratado con cirugía, el Caso 2 tuvo una hemorragia macular multinivel debido a una rotura de un macroaneurisma arteriolar retiniano y fue manejado con desplazamiento neumático, láser y ranibizumab intravítreo, el Caso 3 presentó una hemorragia subretiniana extensa debido a rotura coroidea posterior a un trauma ocular cerrado de alta energía y fue tratado exitosamente con cirugía. El último caso presentó una hemorragia prerretiniana debido a retinopatía diabética, manejada con láser neodymium-doped yttrium aluminium garnet. Los diferentes tratamientos fueron realizados exitosamente con buenos resultados. CONCLUSIÓN: Existen amplias opciones disponibles para el manejo de las hemorragias maculares y la mejor opción depende de las características de cada caso en particular. El manejo apropiado y oportuno de éstas puede lograr un resultado visual bueno, especialmente si la localización de la hemorragia es prerretiniana.

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INTRODUCCIÓN: Las hemorragias maculares producen una pérdida de la visión súbita y profunda. Las principales modalidades de tratamiento incluyen observación, inyección intravítrea de fármacos antiangiogénicos, hialoidotomía con láser neodymium-doped yttrium aluminium garnet, inyección intravítrea de gas y/o activador de plasminógeno tisular, en monoterapia o combinadas con cirugía. En el presente trabajo reportamos cuatro casos de hemorragias maculares de distintas causas, tratadas con diferentes abordajes, y realizamos una revisión de la literatura al respecto. PRESENTACIÓN DE CASOS: Los cuatro pacientes mostrados presentaron diferentes causas de hemorragias maculares. El primer caso tuvo una hemorragia prerretiniana debido a retinopatía de Valsalva y fue tratado con cirugía, el Caso 2 tuvo una hemorragia macular multinivel debido a una rotura de un macroaneurisma arteriolar retiniano y fue manejado con desplazamiento neumático, láser y ranibizumab intravítreo, el Caso 3 presentó una hemorragia subretiniana extensa debido a rotura coroidea posterior a un trauma ocular cerrado de alta energía y fue tratado exitosamente con cirugía. El último caso presentó una hemorragia prerretiniana debido a retinopatía diabética, manejada con láser neodymium-doped yttrium aluminium garnet. Los diferentes tratamientos fueron realizados exitosamente con buenos resultados. CONCLUSIÓN: Existen amplias opciones disponibles para el manejo de las hemorragias maculares y la mejor opción depende de las características de cada caso en particular. El manejo apropiado y oportuno de éstas puede lograr un resultado visual bueno, especialmente si la localización de la hemorragia es prerretiniana.

INTRODUCTION: Macular hemorrhages result in a sudden and profound loss of vision. The primary treatment modalities include observation, intravitreal injection of antiangiogenic drugs, neodymium-doped yttrium aluminum garnet hialoidotomy, intravitreal injection of gas with or without tissue plasminogen activator, as monotherapy or combined with surgery. In this paper, we report four cases of macular hemorrhages of different causes treated with different approaches, and we review the literature in this regard. CASE PRESENTATION: All four patients presented different causes of macular hemorrhage. The first case had a preretinal hemorrhage due to a Valsalva retinopathy and was treated with surgery. Case 2 had a multilevel macular hemorrhage due to a rupture of a retinal arteriolar macroaneurysm and was treated with pneumatic displacement, laser, and intravitreal ranibizumab. Case 3 presented an extensive subretinal hemorrhage due to a choroidal rupture after high-energy ocular trauma that was also successfully treated with surgery. The last case was a preretinal hemorrhage due to diabetic retinopathy managed with neodymium-doped yttrium aluminum garnet laser. Different treatment approaches were successfully performed in all cases with good outcomes. CONCLUSION: There is an extensive range of options available for the management of macular hemorrhages, and the best option depends on the characteristics of each particular case. Proper and timely management of these diseases can achieve an excellent visual outcome, especially if the location of the hemorrhage is preretinal.

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ABSTRACT Purpose: To study the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration. Methods: We used a decision tree model to analyze the cost-effectiveness of ranibizumab and bevacizumab for the treatment of age-related macular degeneration, from the Brazilian Public Health System (SUS) perspective. Ranibizumab and bevacizumab were administered to patients with the same treatment procedure, and the difference in treatment costs was calculated based on the cost of the drugs. Direct costs were estimated using the information provided by the Brazilian SUS. Effectiveness in terms of quality-adjusted life years (QALYs) was calculated based on the utility values for visual impairment. Incremental cost-effectiveness ratio was calculated by comparing both treatments. The analytical horizon was one year. Results: The decision tree analysis showed that the difference in treatment effectiveness was 0.01 QALY. Incremental cost-effectiveness ratio showed that ranibizumab treatment required an incremental annual cost of more than R$ 2 million to generate 1 additional QALY, as compared to bevacizumab. Conclusions: From the Brazilian SUS perspective, bevacizumab is more cost-effective than ranibizumab for the treatment of neovascular age-related macular degeneration. Its use could allow potential annual savings in health budget.

RESUMO Objetivo: Estudar o custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade neovascular. Métodos: Utilizamos um modelo de árvore de decisão para analisar a relação custo-efetividade do ranibizumabe e bevacizumabe no tratamento da degeneração macular relacionada à idade, sob a perspectiva do Sistema Único de Saúde. O ranibizumabe e bevacizumabe foram administrados a pacientes com o mesmo procedimento de tratamento, e a diferença nos custos do tratamernto foi calculada com base no custo dos medicamentos. Os custos diretos foram estimados utilizando as informações fornecidas pelo SUS. A efetividade foi determinada em anos de vida ajustados pela qualidade (QALY) baseados em valores de utilidade em deficiênciavisual. A razãoincremental custo-efetividadefoicalculada comparando os dois tratamentos. O horizonte analítico foi de um ano. Resultados: A análise da árvore de decisão mostrou que a diferença na efetividade do tratamento foi de 0,01 QALY. A razão incremental de custo-efetividade mostrou que o tratamento com ranibizumabe exigiu um custo anual incremental de R$ 2 milhões para gerar um QALY adicional, em comparação ao bevacizumabe. Conclusões: Do ponto de vista do SUS, o bevacizumabe é mais custo-efetivo que o ranibizumabe no tratamento da degeneração macular relacionada à idade neovascular. O seu uso poderia gerar uma grande economia anual para o orçamento em saúde.

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Gold coated magnetite nanoparticles were prepared and coated with ranibizumab as an ocular drug delivery system. The surface morphologies of the nanoparticles were determined by Scanning Electron Microscopy (SEM). The size and surface charge were determined by using the dynamic light scattering (DLS) technique. Crystallographic properties of the gold coated Fe3O4 nanoparticles were recorded on X-ray diffractometer (XRD) the XRD pattern of nanoparticlees were shown to have uniqe Fe3O4 and gold peaks. Conjugation of ranibizumab onto nanoparticles was achieved using the physical adsorption method. The amount of ranibizumab on the surface of the nanoparticles was determined by thermogravimetric analysis (TGA). In the in vitro release studies performed using UV spectroscopy; it was found that almost 60% of antibodies were released within the first 30 minutes. Antibody activity after release studies was also proved with ELISA. Non-toxicity of gold coated Fe3O4 particles were proved with MTT. Results of the studies, showed that the antibody conjugated magnetic nanoparticle system could be a potential treatment system for ocular diseases.

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