A phase III, multicenter, randomized, placebo-controlled clinical trial of topical XXXX (Caprogel) in the management of @entity5891 .

@entity7115 @entity1 @entity5891 @entity548
OBJECTIVE: To determine the safety and efficacy of topical @entity7115 (Caprogel) in the management of @entity5891 . DESIGN: Multicenter, randomized, double-masked, placebo-controlled clinical trial. @entity1 : A total of 51 @entity1 participated in this trial (power = 36%, 2-tailed test). INTERVENTION: @entity1 presenting with @entity5891 were randomly assigned to 5-day treatment with topical @entity7115 or a placebo gel. @entity1 were monitored daily with ocular examination and vital sign testing for the 5 days of treatment and at 24 and 48 hours after treatment. General physical examination and laboratory testing were performed at baseline and day 5. MAIN OUTCOME MEASURES: The main efficacy variable was the rate of rebleeding. Secondary efficacy variables included time to @entity5891 clearance, intraocular pressure, time to secondary @entity548 , and visual acuity. Safety variables included adverse events, vital signs, and laboratory measurements. RESULTS: Rebleeding occurred in 30% of the placebo group (8 of 27; 95% confidence interval [CI] = 14-50%), versus 8% of the treatment group (2 of 24; 95% CI = 1-27%), for an estimated continuity-corrected difference in percentage of @entity1 with @entity548 of 17% (95% CI = -3-38%). Secondary efficacy variables were similar in the groups, except that there was a trend towards more visual improvement in the topical @entity7115 group (54%) than in the placebo group (30%) at the last measurement (P = 0.08). Adverse events were similar. CONCLUSIONS: This study provides evidence that topical @entity7115 is safe and demonstrates trends towards reducing the rebleeding rate in the management of @entity5891 . However, because the study was terminated before complete enrollment, more definitive recommendations will require a larger trial.
