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

Phase 2

Completed

• Conditions: Neovascular (Wet) Age-Related Macular Degeneration
• Interventions: Drug: High-dose aflibercept; Drug: aflibercept

• Registration Number: NCT04126317
• Lead Sponsor: Regeneron Pharmaceuticals

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 and/or longer duration of action compared to intravitreal aflibercept injection (hereafter referred to as IAI).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-11
• Study First Submitted QC: 2019-10-11
• Study First Posted: 2019-10-15
• Study Start: 2019-11-04
• Primary Completion: 2021-05-14
• Study Completion: 2021-11-30
• Disposition First Submitted: 2022-05-12
• Disposition First Submitted QC: 2022-05-12
• Disposition First Posted: 2022-05-13
• Status Verified: 2023-07
• Results First Submitted: 2023-07-21
• Results First Submitted QC: 2023-07-21
• Last Update Submitted: 2023-07-21
• Results First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-dose aflibercept (HD)	High-dose aflibercept	Treatment-naïve patients with nAMD randomized in a 1:1 ratio
intravitreal aflibercept injection (IAI)	aflibercept	Treatment-naïve patients with neovascular "wet" age-related macular degeneration (nAMD) randomized in a 1:1 ratio

Primary Outcome Measures

Name	Time	Method
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)	Up to Week 44
Number of Participants With at Least One Serious TEAE	Up to Week 44
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye	At Week 16	Center subfield=the circular area in 1 millimeter (mm) diameter centered around the center point of the fovea. Without fluid defined as absence of intraretinal fluid (IRF) and/or subretinal fluid (SRF) in the center subfield. Presence of retinal fluid was assessed by spectral domain optical coherence tomography (SD-OCT)

Trial Locations

Locations (1)

Regeneron Study Site; 🇵🇷 Arecibo, Puerto Rico