CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 326 enrolled
Drug / intervention
Ocriplasmin 125µg +1 moredrug
Likely dose
Ocriplasmin 125µgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00798317
NCT00798317Phase 3Completed
CompareCT.gov

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

ThromboGenics·interventional·Posted Nov 26, 2008·Updated Dec 17, 2014

In Brief

A Phase 3 clinical trial evaluating Ocriplasmin 125µg and Placebo for Vitreomacular Adhesion. Completed, enrolled 326 participants across 48 sites in 7 countries.

Detailed Summary

This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVitreomacular Adhesion
CountriesBelgium, Czechia, Germany, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 26, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.6 years ago

Interventions

Ocriplasmin 125µgdrug

125µg of ocriplasmin intravitreal injection

Placebodrug

Intravitreal injection placebo.