Status:
UNKNOWN
Study of Intravitreal Microplasmin in Relieving Vitreo-Macular Adhesion in Neovascular Age-related Macular Degeneration
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
ThromboGenics
Conditions:
Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 hav...
Detailed Description
The human vitreous gel undergoes progressive liquefaction with age. Concurrent with the process of vitreous liquefaction, there is a weakening of the adhesion at the vitreoretinal interface between th...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2011
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00996684
Start Date
October 1 2009
End Date
December 1 2011
Last Update
September 27 2011
Active Locations (1)
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1
Jules Stein Eye Institute/UCLA
Los Angeles, California, United States, 90095