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 |
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Recruitment Status
:
Completed
First Posted
: October 29, 2008
Results First Posted
: January 28, 2013
Last Update Posted
: December 17, 2014
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Sponsor:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
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Brief Summary:
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
| 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 |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | December 2008 |
| Actual Primary Completion Date : | March 2010 |
| Actual Study Completion Date : | April 2010 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Adhesions
Drug Information available for:
Ocriplasmin
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
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Experimental: 125µg Ocriplasmin
125µg intravitreal injection of ocriplasmin
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Drug: 125 µg Ocriplasmin
125µg ocriplasmin intravitreal injection
Other Name: microplasmin
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Placebo Comparator: Placebo
placebo intravitreal injection
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Drug: Placebo
Placebo intravitreal injection
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Primary Outcome Measures
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- 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.
Secondary Outcome Measures
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- 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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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00781859
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Sponsors and Collaborators
ThromboGenics
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | ThromboGenics |
| ClinicalTrials.gov Identifier: | NCT00781859 History of Changes |
| Other Study ID Numbers: |
TG-MV-006 |
| First Posted: | October 29, 2008 Key Record Dates |
| Results First Posted: | January 28, 2013 |
| Last Update Posted: | December 17, 2014 |
| Last Verified: | April 2014 |
Additional relevant MeSH terms:
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Tissue Adhesions Cicatrix Fibrosis Pathologic Processes |
Plasminogen Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action |