Who is sponsoring NCT00781859?

NCT00781859 is sponsored by ThromboGenics.

What condition does NCT00781859 study?

NCT00781859 studies Vitreomacular Adhesion.

What drugs are being tested in NCT00781859?

Interventions: 125 µg Ocriplasmin, Placebo.

What is the status of NCT00781859?

NCT00781859 is currently COMPLETED.

Last reviewed 2014-12-02 · How we verify

A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion

NCT00781859 Phase 3 COMPLETED Results posted

The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.

Details

Lead sponsor	ThromboGenics
Phase	Phase 3
Status	COMPLETED
Enrolment	326
Start date	2008-12
Completion	2010-04

Conditions

Vitreomacular Adhesion

Interventions

125 µg Ocriplasmin
Placebo

Primary outcomes

Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. — Day 28
The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.

Countries

United States