An Open Label, Single Center Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion - MIVI 8

• Conditions: Focal vitreomacular adhesion; MedDRA version: 9.1Level: LLTClassification code 10051065Term: Vitreomacular traction syndrome

• Registration Number: EUCTR2008-005228-10-BE
• Lead Sponsor: ThromboGenics NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09-01
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified