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
We found this trial at
51
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Oceanside, CA
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99-193 Aiea Heights Drive
'Aiea, Hawaii 96701
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Asheville, NC
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Augusta, GA
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Austin, TX
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Baltimore, MD
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Bellevue, WA
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Beverly Hills, California 90211
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Bloomfield, NJ
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Boston, MA
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Charlotte, North Carolina 28207
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Charlotte, NC
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Chicago, IL
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Colorado Springs, Colorado 80910
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Colorado Springs, CO
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Dallas, TX
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Decatur, GA
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Edison, NJ
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Florence, SC
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Florissant, MO
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Fort Worth, TX
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Germantown, TN
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Grand Rapids, MI
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Houston, TX
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Jackson, MI
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Kingston, PA
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Lakeland, FL
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Las Vegas, NV
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Lexington, KY
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Mesa, AZ
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Minneapolis, MN
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Mountain View, California 94040
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Mountain View, CA
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Nashville, TN
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New Albany, IN
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New London, CT
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Palm Desert, CA
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Portland, ME
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Rapid City, SD
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Rochester, NY
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San Antonio, TX
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Shawnee Mission, KS
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Tampa, FL
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Teaneck, NJ
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The Woodlands, TX
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Tucson, AZ
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West Columbia, South Carolina 29169
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West Columbia, SC
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Winter Haven, FL
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