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

Primary Purpose

Focal Vitreomacular Adhesion

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Microplasmin

About this trial

This is an interventional treatment trial for Focal Vitreomacular Adhesion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University Hospital Leuven

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Microplasmin

Arm Description

Outcomes

Primary Outcome Measures

History/full ophthalmologic examination (including full retinal examination: baseline, post-injection days 7, 14 and 28 and months 3 and 6

Secondary Outcome Measures

Proportion of patients with nonsurgical resolution of focal vitreomacular adhesion at study visits other than the 28 day post-injection visit

Full Information

NCT ID

NCT01055535

First Posted

January 22, 2010

Last Updated

April 4, 2014

Sponsor

ThromboGenics

1. Study Identification

Unique Protocol Identification Number

NCT01055535

Brief Title

Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion

Acronym

MIVI-8

Official Title

An Open Label, Single Centre Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion

Study Type

Interventional

2. Study Status

Record Verification Date

April 2014

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

April 2011 (Actual)

Study Completion Date

April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ThromboGenics

4. Oversight

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Focal Vitreomacular Adhesion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

17 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Microplasmin

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Microplasmin

Intervention Description

125 µg intravitreal injection

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Facility Information:

Facility Name

University Hospital Leuven

City

Leuven

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion

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