PATIENT-REPORTED VISUAL FUNCTION FROM THE OCRIPLASMIN FOR TREATMENT FOR SYMPTOMATIC VITREOMACULAR ADHESION, INCLUDING MACULAR HOLE (OASIS) STUDY

Supplemental Digital Content is Available in the Text. Symptomatic vitreomacular adhesion is associated with reduced visual acuity, which can significantly affect quality of life. This study was a prespecified analysis of the 2-year, sham-controlled OASIS trial. Clinically meaningful (≥5-point) changes in patient-reported outcomes were assessed. Ocriplasmin resulted in clinically meaningful improvements in visual function.
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.