Status:
COMPLETED
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Lead Sponsor:
Regeneron Pharmaceuticals
Collaborating Sponsors:
Bayer
Conditions:
Neovascular (Wet) Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief 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 a...
Eligibility Criteria
Inclusion
- Key
- 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
- 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.
Key Trial Info
Start Date :
November 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2021
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04126317
Start Date
November 4 2019
End Date
November 30 2021
Last Update
August 14 2023
Active Locations (46)
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1
Regeneron Study Site
Phoenix, Arizona, United States, 85020
2
Regeneron Study Site
Sun City, Arizona, United States, 85351
3
Regeneron Study Site
Encino, California, United States, 91436
4
Regeneron Study Site
Fullerton, California, United States, 92835