科研之友
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摘要
Purpose: To evaluate the safety and efficacy of a preoperative intravitreous injection of microplasmin in patients scheduled for vitreous surgery. Design: Phase 2, multicenter, placebo-controlled, double-masked, parallel-group, dose-ranging clinical trial. Participants: One hundred twenty-five patients scheduled for pars plana vitrectomy (PPV), primarily for treatment of either vitreomacular traction or macular hole. Intervention: A single intravitreous injection of either microplasmin at 1 of 3 doses (25 mu g, 75 mu g, or 125 mu g in 100 mu l) or placebo injection administered 7 days before PPV. Main Outcome Measures: Presence or absence of posterior vitreous detachment (PVD) at the time of PPV, progression of PVD, and resolution of vitreomacular interface abnormality precluding the need for PPV. Results: Rates of total PVD at the time of surgery were 10%, 14%, 18%, and 31% in the placebo group (n = 30), 25-mu g (n = 29), 75-mu g (n = 33), and 125-mu g microplasmin groups (n = 32), respectively. The secondary end point resolution of vitreomacular interface abnormality precluding the need for vitrectomy at the 35-day time point was observed at rates of 3%, 10%, 15%, and 31% in the placebo, and the 25-mu g, the 75-mu g, and the 125-mu g microplasmin groups, respectively. At the 180-day time point, the equivalent rates were 3%, 7%, 15%, and 28%, respectively. Conclusions: Microplasmin injection at a dose of 125 mu g led to a greater likelihood of induction and progression of PVD than placebo injection. Patients receiving microplasmin were significantly more likely not to require vitrectomy surgery. More definitive evaluation in phase 3 clinical trials therefore is warranted. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references.
- 出版日期2010-4
