Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration

• Status: Active, not recruiting
• Trial end date: 2021-12-06
• Target enrollment: 0
• Participant gender: All

Summary

The primary objectives of the study are to determine the safety of high-dose aflibercept (hereafter referred to as HD) and to determine if HD provides greater intraocular pharmacodynamic (PD) effect and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).

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

Details

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

Criteria

Key Inclusion Criteria:

• Men or women ≥50 years of age with active subfoveal choroidal neovascularization (CNV) secondary to nAMD

• Best Corrected Visual Acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 78 to 24 (Snellen equivalent of 20/32 to 20/320) in the study eye

Key Exclusion Criteria:

• Evidence of CNV due to any cause other than nAMD in either eye

• Evidence of diabetic macular edema (DME) or diabetic retinopathy (defined as more than 1 microaneurysm) in either eye in diabetic patients

• Prior use of IVT anti-VEGF agents (aflibercept, ranibizumab, bevacizumab, brolucizumab, pegaptanib sodium) in the study eye

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

• Previous use of intraocular or periocular corticosteroids within 120 days of screening or treatment with an IVT steroid implant at any time in the study eye

• History of vitreoretinal surgery (including scleral buckling) in the study eye

• Any other intraocular surgery within 12 weeks (84 days) before the screening visit

• History of corneal transplant or corneal dystrophy in study eye

NOTE: Other protocol defined inclusion/exclusion criteria apply.