Anti-vasculaR Endothelial Growth Factor plUs Anti-angiopoietin 2 in Fixed comBination therapY: Evaluation for the Treatment of Diabetic Macular Edema



Status:Completed
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:10/5/2018
Start Date:March 2, 2016
End Date:July 10, 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 Diabetic Macular Edema

The primary objective of the study was to compare the efficacy of intravitreal
(IVT)-administered REGN910-3 compared to intravitreal aflibercept injection (IAI) in
improving best corrected visual acuity (BCVA) in participants with diabetic macular edema
(DME).


Key Inclusion Criteria:

1. Men or women ≥18 years of age with type 1 or type 2 diabetes mellitus who have
clinically significant DME with central involvement in the study eye

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 macular edema due to any cause other than diabetes mellitus in either eye

2. IVT anti-VEGF in the study eye within 12 weeks of the screening visit

3. Panretinal laser photocoagulation or macular laser photocoagulation in the study eye
within 3 months of screening

Note: Other inclusion/ exclusion criteria apply
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Austin, TX
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99-193 Aiea Heights Drive
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Beverly Hills, California 90211
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Charlotte, North Carolina 28207
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Colorado Springs, Colorado 80910
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Mountain View, California 94040
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