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

• Status: Completed
• Trial end date: 2017-07-10
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Bayer
• Treatments: Aflibercept; Endothelial Growth Factors

Criteria

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