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

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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).


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
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