Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration

• Status: Unknown status
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of California, Los Angeles
• Collaborator: ThromboGenics
• Treatments: Fibrinolysin; Plasminogen

Criteria

Inclusion Criteria:

• Male or female subjects aged 50 years or older

• Presence of focal vitreomacular adhesion as seen by OCT

• BCVA of 20/800 or better in non-study eye

• Presence of active choroidal neovascular membrane

• Written informed consent obtained from subject prior to inclusion in the trial

Exclusion Criteria:

• Subjects who have previously received microplasmin

• Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes adequate examination or investigation of study eye

• Patient with uncontrolled glaucoma including IOP >25 mm Hg

• Subjects who have had vitrectomy or retinal detachment or who are aphakic or highly myopic (>8.0 D) in the study eye

• Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods include intrauterine device, oral, implanted or injected contraceptives, and barrier methods with spermicide.

• Subjects who, in the Investigator's view, will not complete all visits and investigations

• Patient who have PDT or any intravitreal injection in the last 10 days. Patients who in the examiners opinion will need intravitreal injection in the next 10 days (apart from microplasmin).

• Patients who have participated in an investigational drug trial in the past 30 days.