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E.L. Thomas, B.D. Kuppermann, L.R. Grillone, North American Vitrase Study Group; A Phase 3 Double-masked, Prospective, Randomized, Placebo-controlled Study of Purified Ovine Hyaluronidase under Investigation for the Treatment of Vitreous Hemorrhage . Invest. Ophthalmol. Vis. Sci. 2003;44(13):4284.
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© ARVO (1962-2015); The Authors (2016-present)
Purpose:To evaluate the safety and efficacy of a single intravitreous injection (50 mL) of Vitrase' (hyaluronidase) compared to 0.9% sodium chloride (control) for vitreous hemorrhage. Methods:Patients with vitreous hemorrhage for >1 month; severe at study entry with best corrected visual acuity (BCVA) 3 lines in BCVA or 0.3 LogMAR) and to permit diagnosis and treatment of the underlying condition. Safety was assessed through 12 months. Results: At baseline, 87.2% of patients had light perception, hand motion or count finger vision. 82.7% were diabetic and mean duration of hemorrhage was 116.9 days. There was a statistically significant improvement in BCVA for patients treated with Vitrase: 29.8% (7.5 IU), 27.9% (55 IU) and 31.5% (75 IU) compared to saline (17.6%) at month 1 (p<0.05). At month 2, efficacy was demonstrated for 39.1% (55 IU) and 40.1% (75 IU) compared to saline (26.4%). Similarly, there was a statistically significant difference in the number of patients with a reduction in hemorrhage density at month 1: 24.9% (7.5 IU), 20.7% (55 IU), and 24.4% (75 IU) compared to 11.4% (saline). This effect persisted through month 3: 40.2% (55 IU) and 42.6% (75 IU) compared to 29.5% (saline). The most common adverse events (p<0.05) were: iritis, hyperemia, irritation, pain, increased lacrimation, photophobia, photopsia. Most resolved by month 1. Although statistically significant, recurrent hemorrhage and visual acuity reduction showed no dose response. Conclusions: The ability of Vitrase to reduce the hemorrhage density sufficiently to diagnose and treat the underlying condition was clinically and statistically significant in this study as was improvement in BCVA. The treatment effect was apparent as early as month 1 and persisted for 2 to 3 months. The 55 IU dose appears to be the optimal dose for safety and efficacy.
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