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Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion (MIVI-8)

This study has been completed.
Sponsor:
Information provided by:
ThromboGenics
ClinicalTrials.gov Identifier:
NCT01055535
First received: January 22, 2010
Last updated: July 18, 2011
Last verified: July 2011
History of Changes
  Purpose

This study will evaluate the safety and efficacy of Microplasmin administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. Ultimately, it is believed that intravitreal microplasmin may offer physicians a safe agent for pharmacologic vitreolysis and induction of Posterior Vitreous Detachment (PVD) without the need for vitrectomy. This clinical study is justified because the study sponsor believes the potential benefits outweigh the potential risks, as outlined below.


Condition Intervention Phase
Focal Vitreomacular Adhesion
 Drug: Microplasmin
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open Label, Single Centre Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion

Resource links provided by NLM:

MedlinePlus related topics: Adhesions
Drug Information available for: Ocriplasmin
U.S. FDA Resources

Further study details as provided by ThromboGenics:

Primary Outcome Measures:
  • History/full ophthalmologic examination (including full retinal examination: baseline, post-injection days 7, 14 and 28 and months 3 and 6 [ Time Frame: baseline, day 7, 14 and 28 and months 3 and 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Proportion of patients with nonsurgical resolution of focal vitreomacular adhesion at study visits other than the 28 day post-injection visit [ Time Frame: Day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microplasmin Drug: Microplasmin
125 µg intravitreal injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • I. Male or female patients aged > 18
  • II. Presence of focal vitreomacular adhesion (ie, central vitreal adhesion within 6mm OCT field surrounded by elevation of the posterior vitreous cortex
  • III. BCVA of 20/32 or worse in the study eye
  • IV. BCVA of 20/400 or better in the contralateral eye
  • V. Written informed consent obtained from the patient prior to inclusion in the study

Exclusion Criteria:

  • I. Evidence of complete macular PVD in the study eye on biomicroscopy, B-scan or OCT prior to planned study drug injection
  • II. Any evidence of proliferative retinopathy meeting the definition for PDR in the study eye
  • III. Patients with vitreous hemorrhage 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
  • IV. Patients with rhegmatogenous retinal detachment, PVR, or retinal degenerative changes associated with increased risk of retinal detachment in the study eye. Such retinal degenerative changes include lattice degeneration or cystic retinal tufts. Thorough retinal examination should be performed in all patients to rule out these changes.
  • V. Patients with high myopia (> 8D) or aphakia in the study eye

VI. Patients with history of rhegmatogenous retinal detachment in the fellow eye VII. Patients who have had ocular surgery in the study eye in the prior three months VIII. Patients who have had a vitrectomy in the study eye at any time. IX. Patients with glaucoma that is not controlled with topical medication or that is associated with severe visual field loss, documented by perimetry, in the study eye X. Patients who have had laser photocoagulation treatment in the study eye in the previous 3 months XI. Intravitreal injection of any drug in the study eye in the previous 3 months XII. Patients who are pregnant or of child-bearing potential not utilizing a form of contraception acceptable to the Investigator XIII. Patients who, in the investigators view, will not complete all visits and investigations, including the last visit at 6 months after the last injection XIV. Patients who have participated in an investigational drug study within the past 30 days XV. Patients with hypertension (either SBP > 170 or DBP > 100 mm Hg) XVI. Patients with a life expectancy less than 6 months XVII. Patients who have previously participated in this trial

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055535

Locations
Belgium
University Hospital Leuven
Leuven, Belgium
Sponsors and Collaborators
ThromboGenics
  More Information

No publications provided

Responsible Party: Edith Van Dijkman, ThromboGenics
ClinicalTrials.gov Identifier: NCT01055535     History of Changes
Other Study ID Numbers: TG-MV-008
Study First Received: January 22, 2010
Last Updated: July 18, 2011
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013