Active — Not RecruitingPhase 3

A Phase 3b, Single-Arm Study of Aflibercept 8 mg Dosed Every 4 Weeks in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)

United States1,118 participantsStarted 2024-07-24

Plain-language summary

This study is researching aflibercept high dose (HD), referred to as "study drug", with an experimental dosing regimen. The study is focused on participants with nAMD and DME that have been previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications. The aim of the study is to see how safe and effective aflibercept HD injections are when given as frequently as every 4 weeks. The study is also looking at what side effects may happen from taking the study drug.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. ≥50 years of age
✓. History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.
✓. ≥18 years of age
✓. History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography \[SD-OCT\]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator
✓. Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (\~150 days) prior to visit 1

Exclusion criteria

✕. Evidence of CNV due to any cause other than nAMD in either eye
✕. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
✕. Active proliferative diabetic retinopathy (DR) in the study eye

What they're measuring

Occurrence of treatment-emergent adverse events (TEAEs)

Timeframe: Through week 24

Occurrence of serious TEAEs

Timeframe: Through week 24

Trial details

NCT IDNCT06491914

SponsorRegeneron Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-26

View on ClinicalTrials.gov More Neovascular Age-Related Macular Degeneration trials