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

Launched by REGENERON PHARMACEUTICALS · Oct 11, 2019

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility 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.

Trial Officials