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rAAV.sFlt-1 in Exudative Age-related Macular Degeneration
NCT01494805Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2011
- Primary completion
- May 2017
- Countries
- 1
- Sponsor
- Lions Eye Institute
- Modality
- Gene Editing, Gene Silencing, AAV Vectors
- Drugs
- AVA-101
- Conditions
- exudative age-related macular degeneration
01
Overview
Phase 2, randomised trial of AVA-101 in exudative age-related macular degeneration (3 arms), sponsored by Lions Eye Institute. Primary endpoint: No sign of unresolved ophthalmic complications, toxicity or systemic complications at 1 month. Started Dec 2011; status: completed.
02
Design
3 arms- Study design
- Randomized
Low Dose rAAV.sFlt-1
1 x 10^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
High Dose rAAV.sFlt-1
1 x 10^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
Control - ranibizumab only
Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).
03
Who it enrols
Patients aged 55 or older with subfoveal CNV secondary to AMD, specific visual acuity criteria, and evidence of a leaking subfoveal choroidal neovascular lesion or CNV under active anti-VEGF management. Excludes patients with prior photodynamic therapy or laser, significant retinal disease other than AMD, or extensive sub-foveal scarring/atrophy.
04
Endpoints
Primary
No sign of unresolved ophthalmic complications, toxicity or systemic complications
Secondary
Maintenance or improvement of vision without the necessity of ranibizumab re-injections
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