Ranibizumab in Myopic Choroidal Neovascularization: The 12-Month Results from the REPAIR Study
The REPAIR study was a phase II, prospective, multicenter, industry-sponsored study (clinical trial registration: http://clinicaltrials.gov/; identifier: NCT01037348) of intravitreal ranibizumab in myopic choroidal neovascularization (CNV). The purpose was to collect data in a validated robust manner to describe the visual, anatomic, and patient-reported outcome measures in a large cohort of treatment-naïve patients with myopic CNV after intravitreal ranibizumab as primary and first-line therapy using a pragmatic retreatment algorithm. Detailed methodology has previously been reported. Briefly, patients were eligible if they had subfoveal or juxtafoveal CNV secondary to pathologic myopia and best-corrected visual acuity (BCVA) of between 20 of 32 and 20 of 320 (78–24 Early Treatment of Diabetic Retinopathy Study letters) in the study eye. Pathologic myopia was defined as myopic spherical equivalent of ≥6 diopters (preoperatively if the eye had previously undergone cataract or refractive surgery) and active CNV was diagnosed using spectral domain optical coherence tomography (OCT) and fundus fluorescein angiography. In the planned interim analysis at 6 months, the mean gain in BCVA was 12.2 letters. This report summarizes the primary, secondary, and exploratory outcomes at 12 months. Demographic and baseline characteristics of 65 enrolled patients across 12 sites are shown in (available at http://aaojournal.org). Median number of injections over 12 months was 3 (mean, 3.6). After the first baseline injection, retreatment rates for proportions of patients over 12 months were 0 (21.5%), 1 (18.5%), 2 (16.9%), and 3 (15.4%). The median time to first retreatment (time to retreatment for 50% of patients) was 2 months (95% confidence interval, 1.25–3.42).