Phase IV study to evaluate genetic variants of VEGF pathway as biomarkers of VEGF Trap-Eye treatment efficacy in subjects with neovascular age-related macular degeneration (wAMD).
- Conditions
- Wet age-related macular degenerationTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2013-002124-17-ES
- Lead Sponsor
- Fundació de Recerca de L?Institut de Microcirurgia Ocular
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
? Men and women ? 50 years of age.
? Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye.
? ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters.
? Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 70
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 124
? Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD,except dietary supplements or vitamins.
? Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye.
? Prior treatment with anti-VEGF therapy in the study eye is not allowed
? No inflammation / infection in or around the eye
? Known hypersensitivity and allergies.
? Ocular surgery in the past other than cataract surgery.
? No other ocular disease that could lead to decrease of VA.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method