Study of a High-Dose Aflibercept in Participants With Diabetic Eye Disease

• Status: Active, not recruiting
• Trial end date: 2023-06-09
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to determine if treatment with high-dose aflibercept (HD) at intervals of 12 or 16 weeks provides non-inferior best corrected visual acuity (BCVA) compared to aflibercept dosed every 8 weeks.

The secondary objectives of the study are as follows:

• To determine the effect of HD vs. aflibercept on anatomic and other visual measures of response

• To evaluate the safety, immunogenicity, and pharmacokinetics (PK) of aflibercept

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Collaborator: Bayer
• Treatments: Aflibercept

Criteria

Key Inclusion Criteria:

• Diabetic macular edema (DME) with central involvement in the study eye

• Best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score of 78 to 24 (approximate Snellen equivalent of 20/32 to 20/320) in the study eye with decreased vision determined to be primarily the result of DME

• Willing and able to comply with clinic visits and study-related procedures

• Provide informed consent signed by study participant or legally acceptable representative

Key Exclusion Criteria:

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

• Active proliferative diabetic retinopathy in the study eye

• IVT anti-VEGF treatment (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) or panretinal laser photocoagulation (PRP) /macular laser photocoagulation within 12 weeks (84 days) or intraocular or periocular corticosteroids within 16 weeks (112 days) of the screening visit in the study eye

• Prior IVT investigational agents in either eye (eg, anti-ang-2/anti-VEGF bispecific monoclonal antibodies, gene therapy, etc.) at any time

• Treatment with ocriplasmin (JETREA®) in the study eye at any time

NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply