Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
This study has been completed.
Information provided by (Responsible Party):
First received: October 28, 2008
Last updated: January 30, 2013
Last verified: January 2013
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by ThromboGenics:
Primary Outcome Measures:
- Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28 [ Time Frame: Day 28 ] [ Designated as safety issue: No ]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.
|Study Start Date:||December 2008|
|Study Completion Date:||April 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00781859
Show 41 Study Locations
Show 41 Study Locations
Sponsors and Collaborators