RESUMO
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.
RESUMO
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.
RESUMO
The present study was an open-label, prospective, uncontrolled and multicenter clinical trial to investigate the safety and effectiveness of bevacizumab (Lumiere®) administered by the intravitreal route for the treatment of neovascular age-related macular degeneration (nAMD). A total of 22 patients without previous treatment with anti-vascular endothelial growth factor were recruited. Monthly therapy with 1.25 mg intravitreal bevacizumab was applied. Adverse events (AE), visual acuity (VA) and central retinal thickness (CRT) were assessed at baseline, day 1 and day 28 after each injection. A total of 87 AEs were reported; most of them were not serious (96.6%), expected (65.5%) and occurred after the third injection (56.3%). The most frequent AE was 'conjunctival hemorrhage' (29.9% of AEs), attributed to the injection procedure. Treatment was not suspended due to safety reasons in any case. After six months, a statistically significant gain of +8.2 (SD±8.8) letters and a CRT reduction of -75.50 µm (SD±120.3) were achieved with unilateral therapy. VA improvement and CRT reduction were also achieved with bilateral therapy, although to a lesser extent. The results of the present study suggested that therapy with a minimum of 3 doses of bevacizumab over a 6-month period was well tolerated and resulted in a sustained response regarding VA improvement and CRT reduction from the beginning of therapy compared with the baseline value. The study protocol was registered at clinicaltrials.gov (ref. no. NCT03668054).
RESUMO
Objetivo: Exponer la experiencia local sobre el tratamiento de las enfermedades retinales con terapias anti factor de crecimiento endotelial vascular (anti-VEGF) y crear conciencia en relación con la atención centrada en el paciente reconociendo el papel de los médicos especialistas en la determinación del tratamiento más apropiado basado principalmente en la evidencia científica, pero también teniendo en cuenta la experiencia y práctica exitosas en el manejo de cada paciente, con base en sus características únicas e individuales. Método: Revisión y comparación de la literatura científica con la experiencia de los autores, en el diagnóstico y tratamiento de las enfermedades que involucran inyecciones intraoculares, haciendo especial énfasis en la degeneración macular relacionada con la edad neo vascular (DMRE-NV), el edema macular diabético (EMD), la retinopatía diabética (RD), edema macular por oclusión venosa de rama de vena central de la retina (ORVR), la oclusión de vena central de la retina (OVCR) y la neo vascularización sub retiniana asociada a miopía patológica (MP). Resultados: la revisión realizada reafirma que tanto cuando hablamos de clases de medicamentos, de algoritmos de tratamiento o de perfiles de paciente, los diferentes agentes de una misma clase terapéutica pueden tener eficacias o perfiles de seguridad variables. Se debe considerar la importancia clínica que representa la valoración adecuada de los resultados pos tratamiento, pero sobre todo, la selección cuidadosa para determinar el agente y esquema más apropiado en la intención de tratar a un paciente. Si bien existen recomendaciones y guías de tratamiento para las patologías, los protocolos en el manejo individualizado y la exposición de estas experiencias de vida real se hacen necesarios, ya que no todos los pacientes ni todas las enfermedades de la retina responden de igual forma a cada agente terapéutico. Conclusión: La efi cacia y seguridad en el uso de las terapias anti-VEGF son aspectos de suma importancia cuando se trata de proporcionar una atención verdaderamente centrada en el paciente. No hay ninguna solución, intervención o alternativa terapéutica que se ajuste a todas las enfermedades oculares complejas, por lo que es importante hacer un balance que considere la evidencia disponible, la experiencia, y las expectativas de los pacientes y tratantes. Esto permitirá acceder a las alternativas terapéuticas adecuadas, en el momento adecuado siempre teniendo en mente los perfiles de eficacia, seguridad, farmacovigilancia activa y los costos asociados a las alternativas terapéuticas utilizadas en el país.
Purpose: To display local experience on treatment for retinal diseases with anti-Vascular Endothelial Growth Factor (anti-VEGF) therapies and to raise awareness regarding patient-centered care, recognizing the role of medical specialists in determining the most appropriate treatment mainly based on scientific evidence, but also considering the successful experience and practice handling each patient, based on their unique and individual characteristics. Method: Review and comparison of scientific literature according to the authors experience to diagnose and treat diseases involving intraocular injections, focusing on Neovascular Age-related Macular Degeneration (NV-AMD), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema due to Branch Retinal Vein Occlusion (BRVO), Central Retinal Vein Occlusion (CRVO) and Sub-retinal Neovascularization associated with Pathological Myopia (PM). Results: the review confi rms that, when speaking of drug classes, treatment algorithms or patient profi les, diff erent agents of the same therapeutic class can result in variable efficacies or safety profiles. The clinical relevance represented by the adequate assessment of post-treatment results must be considered, but specially, the careful screening to determine the most appropriate agent and regimen in the intention-to-treat a patient. Th ough recommendations and treatment guidelines for pathologies exist, protocols in individualized management and exposure of these real-life experiences are necessary, since not all patients or all retinal diseases respond in the same way to each therapeutic agent. Conclusion: Efficacy and safety using anti-VEGF therapies are extremely important when it comes to providing truly patient-centered care. There is no therapeutic solution, intervention or alternative that fi ts all complex ocular diseases, so it is important to weigh the available evidence, the experience and the expectations of both patients and prescribers. Th is will allow to get access to the appropriate therapeutic alternatives, in a timely manner, always considering the efficacy and safety profiles, active pharmacovigilance and the costs associated with the therapeutic alternatives used locally.
Assuntos
Doenças Retinianas/terapia , Educação de Pessoas com Deficiência Visual , Oftalmopatias/terapia , Injeções Intraoculares , Fator A de Crescimento do Endotélio Vascular/uso terapêuticoRESUMO
PURPOSE: To investigate the effect of vitreomacular adhesion (VMA) on the outcome of antiangiogenic treatment for neovascular age-related macular degeneration (AMD). METHODS: Ninety-nine eyes of 83 patients were used in our cohort study. We prospectively evaluated best corrected visual acuity (BCVA) and central retinal thickness (CRT) in patients with neovascular AMD at baseline and 1, 2, 3, 6, and 12 months after treatment with anti-vascular endothelial growth factor (anti-VEGF) agents. All patients were stratified by spectral domain optical coherence tomography into 2 groups (i.e., VMA[+] and VMA[-]) according to the presence or absence of VMA, and the response to treatment was evaluated. RESULTS: Fifty-four eyes (54.5%) were included in the VMA(-) group and 45 eyes (45.5%) comprised the VMA(+) group. In paired comparisons of mean BCVA between baseline and each follow-up visit (1, 2, 3, 6, and 12 months), the VMA(-) group showed statistically significant improvement at 1, 2, and 3 months compared to baseline, and BCVA significantly improved only at 3 months in the VMA(+) group. For both groups, paired comparisons of CRT showed a statistically significant decrease when data obtained at 1, 2, 3, 6, and 12 months were compared to baseline values (p < 0.05). CONCLUSIONS: Posterior VMA is associated with a worse short-term outcome in patients with neovascular AMD treated with anti-VEGF agents.