Trials / Completed
CompletedNCT00798317
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 326 (actual)
- Sponsor
- ThromboGenics · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ocriplasmin 125µg | 125µg of ocriplasmin intravitreal injection |
| DRUG | Placebo | Intravitreal injection placebo. |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-06-01
- Completion
- 2010-07-01
- First posted
- 2008-11-26
- Last updated
- 2014-12-17
- Results posted
- 2013-01-30
Locations
48 sites across 7 countries: United States, Belgium, Czechia, Germany, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT00798317. Inclusion in this directory is not an endorsement.