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)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Na · None · Treatment
Enrollment
1,118actual
Sites
54
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-07-24 | actual | When the study began enrolling |
| Primary completion | 2025-08-26 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-01-07 | estimated | The whole study's end, after follow-up |
| First posted | 2024-07-09 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Neovascular Age-Related Macular Degeneration
- Diabetic Macular Edema
Intervention
- Drug: Aflibercept 8 mg — also filed as EYLEA®HD, BAY86-5321
Primary outcomes
what the primary-completion date above is the date OFOccurrence of treatment-emergent adverse events (TEAEs)
measured Through week 24
Occurrence of serious TEAEs
measured Through week 24
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