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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)

Study acronym: ELARA
StatusActive, Not Recruiting
PhasePhase 3
Started2024-07-24
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 2 of 2 changed
See other at-risk trials from Regeneron

Amendment history

2026-09-19
Primary endpoint(s) modified2 entries, revised
WasOccurrence of serious TEAEs, Occurrence of treatment-emergent adverse events (TEAEs)
NowParticipants With at Least One Serious TEAE, Participants With at Least One Treatment-emergent Adverse Event (TEAE)
Results posted: 2026-09-18
2025-10-13
Study Status, Contacts/Locations v7
Primary completion dateestimated 2025-08-21→confirmed 2025-08-26
Study sites58→54
2025-04-25
Study Status v6
Primary completion date2025-12-15→2025-08-21
Completion date2027-05-03→2027-01-07
2025-03-21
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 1000→confirmed 1118
Study sites25→58
2025-01-09
Study Status, Study Design v4
Enrollment target400→1000
Show 3 earlier versions
2024-11-22
Study Identification, Study Status, Study Description, Eligibility, Contacts/Locations, IPDSharing v3
Primary completion date2026-01-11→2025-12-15
Completion date2027-05-30→2027-05-03
Study sites16→25
Eligibility criteria+166 characters
Key Inclusion Criteria for Participants with nAMD: ≥50 years of age ChoroidalHistory of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, peras 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 Spe [...] main optical coherence tomography [SD-OCT]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator Key Inclusion for All Par [...] cipants: Previously treated with ≥3 anti-VEGF IVT inje [...]
Study title+24 characters
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)
2024-09-20
Study Status, Contacts/Locations v2
Study sites3→16
2024-08-06
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-01-12→2026-01-11
Completion date2027-05-31→2027-05-30
Study sites0→3
2024-07-01
Original filing
Regeneron
148 trials monitored
See 16 trials at risk
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.
Trial Details
NCT Number NCT06491914
Lead Sponsor Regeneron Pharmaceuticals
Conditions Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema
Enrollment 1,126 participants
Start Date 2024-07-24
Primary Completion 2025-08-26 (estimated)
Study Completion 2027-01-07 (estimated)
Updated on ClinicalTrials.gov 2026-09-18