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 |
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).
(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
sites
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