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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01055535
• Date of registration: 22/01/2010
• Primary sponsor: ThromboGenics
• Public title: Safety and Efficacy Study of Microplasmin in for Non-Surgical Treatment of Focal Vitreomacular Adhesion MIVI-8
• Scientific title: An Open Label, Single Centre Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion
• Date of first enrolment: January 2010
• Target sample size: 30
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01055535
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Belgium

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Focal Vitreomacular Adhesion

Intervention(s)

Drug: Microplasmin

Primary Outcome(s)

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(s)

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]

Secondary ID(s)

TG-MV-008

Source(s) of Monetary Support

Please refer to primary and secondary sponsors