Phase 2
Completed N=106
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
Neovascular (Wet) Age-Related Macular Degeneration
Source: ClinicalTrials.gov NCT04126317 ↗
Enrolled (actual)
106
Serious AEs
10.4%
Results posted
Aug 2023
Primary outcomePrimary: Number of Participants With at Least One Treatment-Emergent Adverse Event (TEAE) — 20; 20; 13; 13 Participants
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).
Outcome Measures
| Outcome | Result | p-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 | — |
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.
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. Informational only — not medical advice.