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Ophthalmology. 2010 Apr;117(4):791-7. doi: 10.1016/j.ophtha.2009.11.005.

A placebo-controlled trial of microplasmin intravitreous injection to facilitate posterior vitreous detachment before vitrectomy.

Author information

  • 1Retina Consultants of Houston, Houston, Texas 77030, USA. msbmd@houstonretina.com

Abstract

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 microg, 75 microg, or 125 microg in 100 microl) 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-microg (n = 29), 75-microg (n = 33), and 125-microg 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-microg, the 75-microg, and the 125-microg 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 microg 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.

Copyright 2010 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.

Comment in

  • Microplasmin before vitrectomy. [Ophthalmology. 2011]
PMID:
20138368
[PubMed - indexed for MEDLINE]
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