Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
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|ClinicalTrials.gov Identifier: NCT00781859|
Recruitment Status : Completed
First Posted : October 29, 2008
Results First Posted : January 28, 2013
Last Update Posted : December 17, 2014
|Condition or disease||Intervention/treatment||Phase|
|Vitreomacular Adhesion||Drug: 125 µg Ocriplasmin Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||326 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||March 2010|
|Actual Study Completion Date :||April 2010|
Experimental: 125µg Ocriplasmin
125µg intravitreal injection of ocriplasmin
Drug: 125 µg Ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
Placebo Comparator: Placebo
placebo intravitreal injection
Placebo intravitreal injection
- Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. [ Time Frame: 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.
- Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 [ Time Frame: Day 28 ]The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781859
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