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Phase 2 N=106 Randomized Single-blind Treatment

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

Neovascular (Wet) Age-Related Macular Degeneration

Bottom Line

View on ClinicalTrials.gov: NCT04126317 ↗
Enrolled (actual)
106
Serious AEs
10.4%
Results posted
Aug 2023
Primary outcome: Primary: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 20; 20; 13; 13 Participants

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
aflibercept (Drug); High-dose aflibercept (Drug)
Age
Adult, Older Adult · 50+ yrs
Sex
All
Sponsor
Regeneron Pharmaceuticals
Primary completion
May 2021

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE)		 20; 20; 13; 13; 24; 28 —
PRIMARY
Number of Participants With at Least One Serious TEAE		 1; 2; 0; 0; 4; 5 —
PRIMARY
Number of Participants Without Retinal Fluid in the Center Subfield of Study Eye		 18; 27 —

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).

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04126317). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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