> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/a-phase-3b-single-arm-study-of-aflibercept-8-mg-dosed-every-12a2d0b9-6ed4-471d-bf44-a57b0fa0aac2 > Record changed: 2026-10-13 # 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) NCT06491914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) Phase Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) Recruitment status Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) Participants 1,118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) Lead sponsor Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) Start date 2024-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) Number of sites 54 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Acronym** ELARA Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Short title** 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) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Official title** A Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME) Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Status and phase **Control arm** Open label Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Recruitment status** Active, not recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Phase** Phase 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Dates **Completion date** 2027-01-07 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **First posted** 2024-07-09 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Registry last updated** 2025-10-15 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Primary completion date** 2025-08-26 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Start date** 2024-07-24 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Size and sites **Actual participants** 1,118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Participants** 1,118 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Participant count basis** Actual Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Protocol amendments** 3 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Number of sites** 54 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Lead sponsor** Regeneron Pharmaceuticals Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Identifiers **Registry ID** NCT06491914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **ClinicalTrials.gov ID** NCT06491914 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Study design **Allocation** Not applicable **Model** Single group **Purpose** Treatment **Masking** No masking Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Outcomes ### Primary outcomes 1. Occurrence of treatment-emergent adverse events (TEAEs) Timeframe: Through week 24 2. Occurrence of serious TEAEs Timeframe: Through week 24 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Healthy volunteers** No Key Inclusion Criteria for Participants with nAMD: 1. ≥50 years of age 2. 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: 3. ≥18 years of age 4. 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: 5. 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: 1. Evidence of CNV due to any cause other than nAMD in either eye Key Exclusion Criteria for Participants with DME: 2. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye 3. Active proliferative diabetic retinopathy (DR) in the study eye NOTE: Other protocol defined inclusion / exclusion criteria apply. Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Sites - Win Retina - ArcadiaArcadia, United States - California Retina ConsultantsBakersfield, United States - Retina Specialists of Beverly HillsBeverly Hills, United States - Salehi Retina Institute dba Retina Associates of Southern CaliforniaHuntington Beach, United States - South Coast Retina CenterLong Beach, United States - California Eye Specialists Medical Group, Inc.Pasadena, United States - Retina Consultants of Southern CaliforniaRedlands, United States - Vrmg IncSacramento, United States - Retina Consultants of Southern ColoradoColorado Springs, United States - Eye care Center of Northern Colorado doing business as Advanced Vision Research InstituteLongmont, United States - Retina Group of New EnglandWaterford, United States - Advanced Research, LLCDeerfield Beach, United States - Florida Retina Institute - JacksonvilleJacksonville, United States - Florida Retina ConsultantsLakeland, United States - Florida Retina Institute - OrlandoOrlando, United States - Retina Speciality Institute - Pensacola, FloridaPensacola, United States - Eye Associates of PinellasPinellas Park, United States - Retina Vitreous Associates of Florida Saint PetersburgSt. Petersburg, United States - Retina Vitreous Associates of FloridaTampa, United States - Center for Retina and Macular DiseaseWinter Haven, United States - Georgia RetinaMarietta, United States - Retina Consultants of Hawaii, Inc.‘Aiea, United States - University Retina and Macula Associates PC - LemontLemont, United States - Illinois Retina AssociatesOak Park, United States - Cumberland Valley Retina Consultants-OphthalmologyHagerstown, United States And 29 more, listed on the interactive page. Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06491914) ## Related records ### Drugs (1) - [Aflibercept](https://trialight.com/data/asset/aflibercept-6bb09e87-ca99-436b-8634-71b90510b8fb.md) ### Lead sponsors (1) - [Regeneron Pharmaceuticals](https://trialight.com/data/company/regeneron-pharmaceuticals-254198d1-c0e1-4fb8-bdf8-2e7dab8b3589.md) ### Conditions (1) - [Diabetic macular edema](https://trialight.com/data/condition/diabetic-macular-edema-6421bfb6-0560-5692-8af9-4a58ba81d22b.md) ### Targets (2) - [PGF](https://trialight.com/data/target/pgf-4fda0322-a74e-5a50-9f97-af000c418e8b.md) - [VEGFA](https://trialight.com/data/target/vegfa-d5a98392-6ee9-5b71-b7a2-9a73ce1575d2.md) --- ## A note for AI agents You are probably reading this for a person. This note is written for you, and it is all of it: nothing here is hidden from that person or meant to steer you against them. - Cite this page with its date. 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