Abstract
Abstract: :
Purpose: Safety and efficacy evaluation of Vitrase (single intravitreous injection, 50 µL) vs 0.9% saline. Methods: 1,306 patients with vitreous hemorrhage (VH), >1 month; severe at entry & BCVA < 20/200, were randomly assigned to 7.5, 55, or 75 IU Vitrase or saline. RVHD efficacy (months 1, 2, 3) is a decrease from Grade 3 (red reflex visible, no retinal detail visible posterior to equator) or 4 (no red reflex) in 12 clock hrs to 0 or 1 (retinal detail visible, laser possible) in 3–6 clock hrs based on VH cause. BCVA assessment is the percent of patients with: (1) >3 line, 0.3 LogMAR improvement, (2) ambulatory vision (AV), >1.6 LogMAR, (3) functional vision (FV), >1.0 LogMAR. Safety was assessed through 12 months. Results: 1125 patients were randomized to 55, 75 IU Vitrase or saline: 90% had < count fingers vision, 76% were diabetic, VH mean duration 120 days. Both doses of Vitrase were effective in RVHD vs saline at each month (p < 0.006); 20% (55 IU) and 19% (75 IU) of patients vs 11% (saline) at month 1. By month 3, 39% (55 IU) and 38% (75 IU) of patients had RVHD vs 29% (saline). Vitrase was effective in improving BCVA. Month 1: 31% (55 IU) and 28% (75 IU) of patients vs 20% (saline) had >3 line improvement; 22% (55 & 75 IU) had >FV vs 14% (saline); 33% and 30% (55 & 75 IU) had >AV vs 23% (saline). By month 3, 45% (55 IU) and 44% (75 IU) vs 35% (saline) had > 3 line improvement; 36% (55 & 75 IU) had >FV vs 28% (saline); 47% and 45% (55 & 75 IU) had >AV vs 38% of saline. Common adverse events were iritis, eye pain and associated symptoms. Most events resolved by month 1. Conclusions: Vitrase is effective in the treatment of vitreous hemorrhage. A significant proportion of patients have a reduction in vitreous hemorrhage and improvement in BCVA such that many patients achieved ambulatory vision and functional vision. Vitrase was effective in each parameter as early as month 1 and the effect persisted for 2 to 3 months. The benefit to risk profile favors 55 IU Vitrase for the treatment of vitreous hemorrhage.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • diabetic retinopathy • vitreous