A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy

ThromboGenics3 sites in 2 countries60 target enrollmentDecember 2004

ConditionsVitreomacular Traction Maculopathy Eye Diseases

InterventionsMicroplasmin

DrugsMicroplasmin

Overview

Phase: Phase 2
Intervention: Microplasmin
Conditions: Vitreomacular Traction Maculopathy
Sponsor: ThromboGenics
Enrollment: 60
Locations: 3
Primary Endpoint: Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.

Detailed Description

Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.

Registry

clinicaltrials.gov

Start Date

December 2004

End Date

November 2008

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

ThromboGenics

Eligibility Criteria

Inclusion Criteria

•Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:
•Macular edema associated with vitreomacular traction (DME, VMTS);
•Stage II-III macular hole of \< 6 months duration since symptom onset;
•Demonstration of vitreomacular adhesion (based on preoperative optic coherence tomography \[OCT\]) in the study eye;
•OCT - presence of posterior hyaloid membrane inserting on to the macula, but with some area of clear separation visible between the retina and the posterior hyaloid.

Exclusion Criteria

•Evidence of fibrocellular proliferation characterized by whitish epimacular tissue (surface wrinkling is not an exclusion criterion).
•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.
•Patients with rhegmatogenous retinal detachment, proliferative vitreoretinopathy (PVR), or retinal degenerative changes in the study eye.
•Patients with high myopia or aphakia in the study eye
•Patients with history of rhegmatogenous retinal detachment in the fellow eye or family history of retinal detachment
•Patients who are considered likely to require intraocular surgery in the study eye for any reason other than vitreomacular traction maculopathy/macular edema in the coming three months.
•Patients who have had ocular surgery in the study eye in the prior three months.
•Patients who have had a vitrectomy in the study eye at any time.
•Patients with a history of uveitis or significant trauma in the study eye.
•Patients who are currently being treated for glaucoma in the study eye.