AUG 20, 2010
This double-masked, Phase II trial randomized 60 patients with vitreomacular adhesion to microplasmin injection (three cohorts received one of three doses: 75-, 125-, or 175- µg) or sham injection. A quarter of the 125-mg group was allowed repeated injections. Patients were followed-up at 28 days, three months, and six months.
Vitreomacular adhesion resolved in nearly half (44 percent) of patients receiving a single 125-µg injection by day 28 and in 58 percent of patients in the repeat-injection group by 28 days after final injection. Macular hole closure occurred in five of 14 patients, including three of 12 Stage II macular holes, with vitreomacular adhesion resolving at or before macular hole closure in all cases. A significantly higher proportion of treated patients achieved total posterior vitreous detachment than controls at day 90 (P=0.033). Only two patients had total posterior vitreous detachment at or before macular hole closure. Treatment was well-tolerated.
The authors advise that while the results of this study are encouraging, a larger Phase III study is necessary to confirm the findings.