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

Focal Vitreomacular Adhesion Clinical Trial

— MIVI-8  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01055535
• Other study ID #: TG-MV-008
• Status: Completed
• Phase: Phase 2
• First received: January 22, 2010
• Last updated: April 4, 2014
• Start date: January 2010
• Est. completion date: April 2011

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Focal Vitreomacular Adhesion
• Tissue Adhesions

Intervention

Drug:
• Microplasmin
125 µg intravitreal injection

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	History/full ophthalmologic examination (including full retinal examination: baseline, post-injection days 7, 14 and 28 and months 3 and 6		baseline, day 7, 14 and 28 and months 3 and 6	Yes
Secondary	Proportion of patients with nonsurgical resolution of focal vitreomacular adhesion at study visits other than the 28 day post-injection visit		Day 28	No