A Placebo-Controlled Trial of Microplasmin Intravitreous Injection to Facilitate Posterior Vitreous Detachment before Vitrectomy

Received 3 April 2009; received in revised form 3 November 2009; accepted 3 November 2009. published online 05 February 2010.
Corrected Proof

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

Available online: •••.

1 Retina Consultants of Houston, Houston, Texas

2 Rush University, Chicago, Illinois

3 Valley Retina Institute, McAllen, Texas

4 ThromboGenics, Inc., New York, New York

5 Wills Eye Institute, Philadelphia, Pennsylvania

6 Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, California

Correspondence Matthew S. Benz, MD, Retina Consultants of Houston, 6560 Fannin, Suite 750, Scurlock Tower, Houston, TX 77030

Manuscript no. 2009-464.

The author(s) have made the following disclosure(s): V. Gonzalez - Consultant - Eyetech; Lecturer - Genentech and Ista S. Pakola - Employee and Equity Owner - ThromboGenics D. Bezner - Employee - ThromboGenics S. D. Schwartz - Lecturer – ThromboGenics The trial was funded by ThromboGenics NV, Leuven, Belgium.

PII: S0161-6420(09)01293-7

doi:10.1016/j.ophtha.2009.11.005