Abstract
Abstract: :
Purpose: Evaluate safety and efficacy of ovine hyaluronidase (single intravitreous injection, 50 µL) compared to 0.9% saline. Methods: 556 patients with VH for >1 month; severe at entry with best corrected visual acuity (BCVA) <20/200 were randomized to 55 or 75 IU Vitrase or saline. Efficacy (months 1, 2 and 3) measured as the ability of Vitrase to: (1) improve visual function (>3 lines in BCVA or 0.3 LogMAR), (2) clear the hemorrhage sufficiently to diagnose and treat the underlying condition, and (3) reduce VH density (RVHD), 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. Safety was assessed through 12 months. Results: At baseline, 95% of patients had < count fingers vision; 71% were diabetic; mean duration of VH was 125 days. Statistical significance was reached in all 3 efficacy parameters in the subset of diabetic patients that were diabetics as early as month 1 for patients treated with 55 IU Vitrase compared to saline (p<0.015): 35% of diabetic patients had BCVA improvement compared to 21% (saline), 23% had sufficient VH clearance to diagnose and treat and RVHD compared to 9% and 10%, respectively for saline. These effects persisted through months 2 and 3 (p<0.015). Patients treated with 75 IU showed improvement in all 3 parameters compared to saline. The common adverse events were: iritis, hyperemia, eye pain and associated symptoms. Most resolved by month 1. Conclusions: Vitrase was effective for the treatment of VH in a subset of patients that were diabetic. The ability of 55 IU Vitrase to reduce the VH density sufficiently to diagnose and treat the underlying condition was clinically and statistically significant as was improvement in BCVA. The efficacy was apparent as early as month 1 and persisted for 2 to 3 months in those patients treated with 55 IU Vitrase. Ocular adverse events were transient and easily managed.
Keywords: diabetic retinopathy • retina • vitreous