Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00798317
First received: November 25, 2008
Last updated: April 4, 2014
Last verified: April 2014

November 25, 2008
April 4, 2014
December 2008
June 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 ]
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at day 28, as determined by masked Central Reading Centre (CRC) OCT evaluation. [ Time Frame: Day 28 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00798317 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 ]
Proportion of subjects with total PVD at Day 28, as determined by masked investigator assessment of B-scan ultrasound.
Proportion of subjects with total PVD at day 28, as determined by masked investigator assessment of B-scan ultrasound. [ 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-007) Trial.
A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion.

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.

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: Ocriplasmin 125µg
    125µg of ocriplasmin intravitreal injection
    Other Name: Microplasmin
  • Drug: Placebo
    Intravitreal injection placebo.
  • Experimental: Ocriplasmin 125µg
    125µg of ocriplasmin intravitreal injection
    Intervention: Drug: Ocriplasmin 125µg
  • Placebo Comparator: Placebo
    Intravitreal injection of placebo
    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
July 2010
June 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm 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,   Belgium,   Czech Republic,   Germany,   Poland,   Spain,   United Kingdom
 
NCT00798317
TG-MV-007
Yes
ThromboGenics
ThromboGenics
Not Provided
Not Provided
ThromboGenics
April 2014

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