Anti-angiOpoeitin 2 Plus Anti-vascular eNdothelial Growth Factor as a therapY for Neovascular Age Related Macular Degeneration: Evaluation of a fiXed Combination Intravitreal Injection
Status: | Completed |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 50 - Any |
Updated: | 10/22/2017 |
Start Date: | March 2016 |
End Date: | October 3, 2017 |
A Randomized, Double-Masked, Active-Controlled Phase 2 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal REGN910-3 in Patients With Neovascular Age-Related Macular Degeneration
The primary objective of the study is to compare the efficacy of intravitreal
(IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
(IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI).
Key Inclusion Criteria:
1. Men or women ≥50 years of age with active subfoveal CNV secondary to AMD, including
juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye as
assessed by a central reading center
2. BCVA ETDRS letter score of 73 to 24 (Snellen equivalent of 20/40 to 20/320) in the
study eye.
3. Willing and able to comply with clinic visits and study-related procedures.
4. Provide signed informed consent.
Key Exclusion Criteria:
1. Evidence of CNV due to any cause other than AMD in either eye
2. Prior IVT anti-VEGF in the study eye
3. Evidence of DME or diabetic retinopathy (defined as more than 1 microaneurysm) in
either eye in diabetic patients
4. Any history of macular hole of stage 2 and above in the study eye
We found this trial at
77
sites
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