Status:
COMPLETED
Safety and Efficacy Study of rAAV.sFlt-1 in Patients With Exudative Age-Related Macular Degeneration
Lead Sponsor:
Lions Eye Institute, Perth, Western Australia
Collaborating Sponsors:
Adverum Biotechnologies, Inc.
Conditions:
Macular Degeneration
Age-related Maculopathies
Eligibility:
All Genders
55+ years
Phase:
PHASE1
PHASE2
Brief Summary
The study will involve approximately 40 subjects aged 55 or above who have exudative age-related macular degeneration (wet AMD). Patients will be randomized to receive one of two doses of rAAV.sFlt-1 ...
Detailed Description
A new treatment for exudative age-related macular degeneration (wet AMD) is being investigated. The purpose of this Phase I/II clinical research study is to examine the baseline safety and efficacy of...
Eligibility Criteria
Inclusion
- Age greater than or equal to 55 years;
- Subfoveal CNV secondary to AMD and with best corrected visual acuity of 3/60 - 6/9 with 6/60 or better in the other eye;
- Fluorescein angiogram of the study eye must show evidence of a leaking subfoveal choroidal neovascular lesion, or CNV currently under active management with anti-VEGF therapy;
- Must be a candidate for anti-VEGF intravitreal injections;
- No previous retinal treatment of photodynamic therapy or laser;
- Able to provide informed consent;
- Able to comply with protocol requirements, including follow-up visits.
Exclusion
- Liver enzymes \> 2 X upper limit of normal;
- Any prior treatment for AMD in the study / control eye, excluding anti-VEGF injections;
- Extensive sub-foveal scarring, extensive geographic atrophy, or thick subretinal blood in the study eye as determined by the investigator;
- Significant retinal disease other than sub-foveal CNV AMD;
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2017
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01494805
Start Date
December 1 2011
End Date
August 1 2017
Last Update
September 1 2017
Active Locations (1)
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1
Lions Eye Institute
Nedlands, Western Australia, Australia, 6009