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

Overview

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).

Full Title of Study: “A Randomized, Single-Masked, Active-Controlled Phase 2 Study of the Safety, Tolerability, and Efficacy of Repeated Doses of High-Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Participant)
  • Study Primary Completion Date: May 14, 2021

Interventions

  • Drug: aflibercept
    • Intravitreally (IVT) administered as a liquid formulation in a vial
  • Drug: High-dose aflibercept
    • Intravitreally (IVT) administered as a liquid formulation in a vial

Arms, Groups and Cohorts

  • Experimental: intravitreal aflibercept injection (IAI)
    • Treatment-naïve patients with neovascular “wet” age-related macular degeneration (nAMD) randomized in a 1:1 ratio
  • Experimental: High-dose aflibercept (HD)
    • Treatment-naïve patients with nAMD randomized in a 1:1 ratio

Clinical Trial Outcome Measures

Primary Measures

  • Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)
    • Time Frame: Up to Week 44
  • Number of Participants With at Least One Serious TEAE
    • Time Frame: Up to Week 44
  • Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye
    • Time Frame: 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)

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 50 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regeneron Pharmaceuticals
  • Collaborator
    • Bayer
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Management, Study Director, Regeneron Pharmaceuticals

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