RESUMO
Objective: To evaluate the short-term result of retinal functional behavior in patients with dry age-related macular degeneration (AMD) corrected by photobiomodulation (PBM) with 670 nm light-emitting diode (LED) light. Materials and methods: Ten patients with dry AMD underwent a treatment consisting of nine PBM sessions with LED light of 670 nm with two cycles of 50 mW/cm2, producing 4 J/cm2 per dose in 88 sec. The studied eye was compared with the baseline (before therapy), and after nine PBM sessions, the following aspects were evaluated: best-corrected visual acuity (VA), retinal sensitivity, and characteristics of the correction area by the fundus automated perimetry using the Compass system. A functional and structural assessment of the retina was also performed using the multifocal electroretinography (ERG), optical coherence tomography (OCT), fluorescence retinography (FR), and autofluorescence (AF). All examinations were performed 1, 4, and 16 weeks after the therapy. The Chi-square and Student's t-tests were used for comparisons. The analyses followed the 95% confidence level (p-value ≤0.05). Results: The BCVA significantly improved, from an average of 1.1 to 0.98 LogMAR (p = 0.01). The visual field examination, according to the parameters of mean deviation, standard deviation, and index of deviation of background perimeter, showed a significant improvement of -12.6% to -10.6%, 10.54% to 9.89%, and 56% to 60%, respectively (p = 0.02, 0.03, and 0.02, respectively). No participant had an adverse effect during the follow-up period; neither did any participant experience abnormalities in OCT, ERG, FR, and AF findings. Conclusions: In this short-term study, the PBM technique in patients with dry AMD showed the potential to improve VA and macular perimetry without causing significant adverse events. A larger number of patients and a longer follow-up will be necessary to further assess the success of this technique in these patients.
Assuntos
Degeneração Macular , Eletrorretinografia , Humanos , Degeneração Macular/radioterapia , Retina/diagnóstico por imagem , Acuidade Visual , Testes de Campo VisualRESUMO
BACKGROUND AND OBJECTIVE: To describe the 6-month safety and preliminary efficacy outcomes of the use of 16-Gy radiation with intravitreal ranibizumab for patients with neovascular age-related macular degeneration (AMD). PATIENTS AND METHODS: A single treatment of a non-invasive, externally delivered low-voltage 16-Gy x-ray irradiation was administered in one session through three locations in the inferior pars plana. Optical coherence tomography (OCT) and Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity (VA) examinations were performed at 1 week, 1 month, and monthly thereafter, with quarterly fluorescein angiography (FA). After the two initial ranibizumab injections, subsequent injections were administered according to the following criteria: VA decline of 10 ETDRS letters compared with baseline, increase of 100-µm central foveal thickness on OCT compared with baseline, the development of new submacular hemorrhage, and the development of a new area of classic choroidal neovascularization on FA. RESULTS: Twenty-six patients completed a 6-month follow-up. There was no evidence of radiation retinopathy, optic neuropathy, or cataract. The mean baseline ETDRS score was 46.6 letters (range: 5 to 80; standard deviation [SD]: 21.5). At 6 months, the corresponding ETDRS score was 55.6 letters (range: 25 to 80; SD: 18.9) and the mean change in VA was 9.5 ETDRS letters (SD: 10.3). On responder analysis, 96% lost 15 or fewer ETDRS letters, 81% gained 0 or more ETDRS letters, and 50% gained 15 or more ETDRS letters. Patients received a total of 13 ranibizumab injections following two initial injections. At 6 months, patients received an average of 0.5 additional injections following the initial two mandated injections. CONCLUSION: A single treatment of externally applied, non-invasive 16-Gy low-voltage x-ray therapy in conjunction with ranibizumab demonstrated an overall improvement of VA in patients with neovascular AMD at 6 months with no radiation-related adverse effects.
Assuntos
Inibidores da Angiogênese/uso terapêutico , Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Degeneração Macular/tratamento farmacológico , Degeneração Macular/radioterapia , Idoso , Idoso de 80 Anos ou mais , Terapia Combinada/métodos , Feminino , Humanos , Injeções Intravítreas , Masculino , Pessoa de Meia-Idade , Dosagem Radioterapêutica , Ranibizumab , Acuidade VisualRESUMO
PURPOSE: The purpose of this study was to evaluate the short-term safety and feasibility of intraocular, epiretinal delivery of beta radiation for the treatment of subfoveal choroidal neovascularization secondary to age-related macular degeneration for 12 months. A 3-year follow-up period is planned to assess the long-term safety of the procedure. METHODS: In this nonrandomized, multicenter feasibility study, 34 treatment-naïve patients with predominantly classic, minimally classic, or occult lesions due to subfoveal choroidal neovascularization secondary to age-related macular degeneration received a single treatment with either 15 Gray (Gy) (8 patients) or 24 Gy (26 patients) beta radiation (strontium-90) using a novel intraocular delivery device. Adverse events and safety endpoints were observed and recorded. Visual acuity was measured preoperatively and postoperatively using standard Early Treatment Diabetic Retinopathy Study vision charts. RESULTS: Twelve months after treatment, no adverse events associated with exposure to radiation were observed. All patients in both 15 Gy (n = 4) and 24 Gy cohorts (n = 17) who met inclusion criteria and were treated according to protocol lost fewer than three lines of vision. Fifty percent (2/4) of the 15 Gy-treated patients and 76% (13/17) of the 24 Gy-treated patients improved or maintained their visual acuity at 12 months. In the 24 Gy group, 29% (5/17) gained three lines or more in visual acuity. The mean change in visual acuity observed at month 12 was +10.3 letters in the 24 Gy study cohort and -1.0 letters in the 15 Gy cohort. CONCLUSION: The short-term safety and efficacy of intraocular, epiretinal delivery of beta radiation for the treatment of subfoveal choroidal neovascularization was promising in this small study group and should be studied in a larger cohort of patients.
Assuntos
Neovascularização de Coroide/radioterapia , Degeneração Macular/radioterapia , Retina/efeitos da radiação , Acuidade Visual/fisiologia , Idoso , Idoso de 80 Anos ou mais , Neovascularização de Coroide/etiologia , Neovascularização de Coroide/fisiopatologia , Estudos de Viabilidade , Feminino , Angiofluoresceinografia , Seguimentos , Fóvea Central , Humanos , Degeneração Macular/complicações , Degeneração Macular/fisiopatologia , Masculino , Pessoa de Meia-Idade , Dosagem Radioterapêutica , Radioisótopos de Estrôncio/efeitos adversos , Radioisótopos de Estrôncio/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND/AIMS: This study evaluated the short-term safety and feasibility of epiretinal strontium-90 brachytherapy delivered concomitantly with intravitreal bevacizumab for the treatment of subfoveal CNV due to AMD for 12 months. A 3-year follow-up is planned. METHODS: In this prospective, non-randomised, multicentre study, 34 treatment-naïve patients with predominantly classic, minimally classic and occult subfoveal CNV lesions received a single treatment with 24 Gy beta radiation (strontium-90) and two injections of the anti-VEGF antibody bevacizumab. Adverse events were observed. BCVA was measured using standard ETDRS vision charts. RESULTS: Twelve months after treatment, no radiation-associated adverse events were observed. In the intent-to-treat (ITT) population, 91% of patients lost <3 lines (15 ETDRS letters) of vision at 12 months, 68% improved or maintained their BCVA at 12 months, and 38% gained >/=3 lines. The mean change in BCVA observed at month 12 was a gain of 8.9 letters. CONCLUSION: The safety and efficacy of intraocular, epiretinal brachytherapy delivered concomitantly with anti-VEGF therapy for the treatment of subfoveal CNV secondary to AMD were promising in this small study population. Long-term safety will be assessed for 3 years. This regimen is being evaluated in a large, multicentre, phase III study.
Assuntos
Inibidores da Angiogênese/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Neovascularização de Coroide/radioterapia , Degeneração Macular/radioterapia , Compostos Radiofarmacêuticos/uso terapêutico , Radioisótopos de Estrôncio/uso terapêutico , Idoso , Idoso de 80 Anos ou mais , Anticorpos Monoclonais Humanizados , Bevacizumab , Braquiterapia/métodos , Neovascularização de Coroide/complicações , Neovascularização de Coroide/tratamento farmacológico , Terapia Combinada , Feminino , Humanos , Degeneração Macular/complicações , Degeneração Macular/tratamento farmacológico , Masculino , Pessoa de Meia-Idade , Projetos Piloto , Estudos Prospectivos , Segurança , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Acuidade VisualRESUMO
Objetivos: Determinar si dosis bajas de radiación alteran el curso natural de la neovascularización subfoveal en pacientes con degeneración macular relacionada con la edad (DMRE). Material y métodos: Se estudiaron pacientes con DMRE tipo húmeda determinándose edad, sexo, agudeza visual, transparencia del cristalino, campimetría computadorizada, extensión de la membrana por angiofloresceinografía y ultrasonido modo A y B. Se trataron con acelerador lineal de rayos X con dosis total de 1,500 cGy, fraccionada en 10 sesiones de 150 cGy, con haz de fotones de alta energía de 10 megaelectrón-volts. Seguimiento 18 meses. Resultados: Se trataron 34 pacientes con DMRE. La capacidad visual se mantuvo estable en 80 por ciento de los casos y 7 pacientes (20 por ciento) presentaron mejoría de una línea de visión, el campo visual se mantuvo estable en 82 por ciento, y el 18 por ciento mejoró; 6 pacientes mostraron un aumento en la opacidad del cristalino. El ultrasonido modo AB demostró reducción del grosor de la membrana neovascular subfoveal en un 34 por ciento (p<0,01). El área de extensión de la membrana también se redujo en 37.23 por ciento (p<0,05). Finalmente la respuesta global al tratamiento fue calificada como buena en el 55.8 por ciento y moderada para el 44.11 por ciento de los casos. Conclusión: Demostramos la utilidad de la radioterapia externa como un tratamiento alternativo para detener el crecimiento de la membrana neovascular subretiniana, manteniendo campo periférico, en pacientes con DMRE de tipo húmedo, cambiando la evolución natural de la enfermedad.