RESUMO
PURPOSE: To evaluate patient-reported visual function after ocriplasmin through the 25-item National Eye Institute Visual Function Questionnaire (VFQ-25) in patients with symptomatic vitreomacular adhesion/vitreomacular traction including macular hole. METHODS: This was a prespecified analysis of a secondary endpoint from the OASIS trial. Patients received a single intravitreal injection of ocriplasmin (0.125 mg) or sham and completed the VFQ-25 questionnaire at baseline and at Months 6, 12, and 24. Clinically meaningful (≥5-point) changes from baseline were assessed. RESULTS: Of the 220 patients enrolled, 146 received ocriplasmin and 74 received sham. At Month 24, the percentage of patients with a ≥5-point improvement from baseline in VFQ-25 composite scores was higher with ocriplasmin versus sham (51.4% vs. 30.1%, 95% confidence interval, 8.1-34.5, P = 0.003). The percentage of patients with ≥5-point worsening at Month 24 was lower with ocriplasmin versus sham (9.5% vs. 15.6%, 95% confidence interval: -15.6 to 3.5, P = 0.191). A larger percentage of patients treated with ocriplasmin versus sham experienced a ≥5-point improvement in VFQ-25 composite and subscale scores at Month 24 regardless of baseline full-thickness macular hole status. CONCLUSION: A larger percentage of patients with symptomatic vitreomacular adhesion/vitreomacular traction reported clinically meaningful improvements in self-assessed visual function with ocriplasmin than sham.
Assuntos
Medidas de Resultados Relatados pelo Paciente , Retina/patologia , Perfurações Retinianas/tratamento farmacológico , Tomografia de Coerência Óptica/métodos , Acuidade Visual , Corpo Vítreo/patologia , Idoso , Método Duplo-Cego , Feminino , Fibrinolisina , Humanos , Injeções Intravítreas , Masculino , Fragmentos de Peptídeos , Perfurações Retinianas/diagnóstico , Inquéritos e QuestionáriosRESUMO
PURPOSE: To evaluate the effects of ocriplasmin and symptomatic vitreomacular adhesion resolution on visual fixation and macular sensitivity using microperimetry. METHODS: MP-1 parameters were analyzed from 3 OASIS sites after the use of standardized instruments and testing procedures over 24 months. RESULTS: A total of 27 patients (19 ocriplasmin, 8 sham) were evaluated. Mean distance of the preferred fixation locus to the anatomical center was farther in the sham group at baseline and farther in the sham versus ocriplasmin group throughout the study. Retinal sensitivity values were consistently higher in the ocriplasmin versus sham group after Month 3. Fewer patients in the ocriplasmin group had predominantly eccentric fixation at study end compared with the sham group, which also had an increased number of patients with unstable fixation. Patients with vitreomacular adhesion resolution had lower bivariate contour area, fewer relative scotomas, and higher retinal sensitivity parameters at baseline than those with unresolved vitreomacular adhesion. CONCLUSION: Substudy results suggest that fixation and sensitivity parameters tended to be better in the ocriplasmin group than in the sham group over time. The substudy identified parameters that were distinct between patients with and without vitreomacular adhesion resolution, suggesting that microperimetry warrants further study as a relevant biomarker for visual function.
Assuntos
Fibrinolisina/administração & dosagem , Fragmentos de Peptídeos/administração & dosagem , Perfurações Retinianas/tratamento farmacológico , Acuidade Visual , Testes de Campo Visual/métodos , Campos Visuais/fisiologia , Descolamento do Vítreo/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Estudos Cross-Over , Relação Dose-Resposta a Droga , Método Duplo-Cego , Feminino , Seguimentos , Humanos , Injeções Intravítreas , Macula Lutea/patologia , Masculino , Pessoa de Meia-Idade , Perfurações Retinianas/diagnóstico , Perfurações Retinianas/etiologia , Fatores de Tempo , Aderências Teciduais/tratamento farmacológico , Aderências Teciduais/patologia , Tomografia de Coerência Óptica , Resultado do Tratamento , Corpo Vítreo/patologia , Descolamento do Vítreo/complicações , Descolamento do Vítreo/diagnósticoRESUMO
PURPOSE: To explore a possible association between full-field electroretinograms with vitreomacular adhesion resolution and best-corrected visual acuity as part of the prospective, randomized, double-masked, sham-controlled Ocriplasmin for Treatment for Symptomatic Vitreomacular Adhesion Including Macular Hole (OASIS) trial studying ocriplasmin. METHODS: The ERG substudy enrolled 62 of 220 OASIS subjects (randomized 2:1) and analyzed full-field electroretinograms and their association with both vitreomacular adhesion resolution and best-corrected visual acuity from baseline through Month 24. Electroretinogram reductions were defined as acute full-field electroretinogram reductions in amplitude of ≥40% from baseline occurring at postinjection Day 7 or Day 28. RESULTS: In the ocriplasmin group, 16/40 (40%) subjects developed ERG reductions, compared to 1/21 (4.8%) in the sham group; 13/16 (81.3%) and 1/1 (100%) resolved by study end, respectively. A total of 11/16 (68.8%) ocriplasmin-treated subjects with ERG reductions achieved vitreomacular adhesion resolution, compared to those without (9/24, 37.5%). The ocriplasmin-treated subjects with ERG reductions also gained more letters on average (11.3 vs. 9.3 letters) from baseline and had a difference of 6.7 letters in mean best-corrected visual acuity by study end compared to those without ERG reductions. CONCLUSION: Ocriplasmin-treated subjects with ERG reductions had a higher rate of vitreomacular adhesion resolution and showed better visual improvement than their counterparts without ERG reductions or sham subjects by study end.
