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.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00781859
First received: October 28, 2008
Last updated: January 30, 2013
Last verified: January 2013

October 28, 2008
January 30, 2013
December 2008
March 2010   (final data collection date for primary outcome measure)
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.
Portion of subjects wiht nonsurgical resolution of focal vitreomacular adhesion at day 28. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00781859 on ClinicalTrials.gov Archive Site
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.
Total PVD [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Vitreomacular Adhesion
  • Drug: 125 µg Ocriplasmin
    125µg ocriplasmin intravitreal injection
    Other Name: microplasmin
  • Drug: Placebo
    Placebo intravitreal injection
  • Experimental: 125µg Ocriplasmin
    125µg intravitreal injection of ocriplasmin
    Intervention: Drug: 125 µg Ocriplasmin
  • Placebo Comparator: Placebo
    placebo intravitreal injection
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
326
April 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)

Exclusion Criteria:

  • Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye.
  • Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either OCT and/or fluorescein angiogram in the study eye.
  • Subjects with macular hole diameter > 400 μm in the study eye.
  • Aphakia in the study eye.
  • High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion).
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00781859
TG-MV-006
Yes
ThromboGenics
ThromboGenics
Not Provided
Not Provided
ThromboGenics
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP