A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
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.
Key Inclusion Criteria for Participants with nAMD:
≥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.
Key Inclusion Criteria for Participants with DME:
≥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
Key Inclusion for All Participants:
Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (~150 days) prior to visit 1
Key Exclusion Criteria for Participants with nAMD:
Evidence of CNV due to any cause other than nAMD in either eye
Key Exclusion Criteria for Participants with DME:
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
NOTE: Other protocol defined inclusion / exclusion criteria apply.
Huntington Beach, California 92647, United States
Longmont, Colorado 80503, United States