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NCT06491914Active, 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)

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 · Last updated 18 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1126 (actual)
First submitted
1 Jul 2024
Start date
24 Jul 2024
Primary completion date
26 Aug 2025
Lead sponsor
Regeneron Pharmaceuticals
NCT number
NCT06491914

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1126
  • From 24 Jul 2024 to the primary completion date, 26 Aug 2025
  • 54 sites in 2 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye

Other

  • Evidence of CNV due to any cause other than nAMD in either eye
  • Active proliferative diabetic retinopathy (DR) in the study eye
    • NOTE: Other protocol defined inclusion / exclusion criteria apply.

Who the study is looking for

  • ≥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
    • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (54)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Emanuelli Research and Development Center
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AreciboPuerto RicoUnknown status
Retina Research Institute of Texas
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AbileneUnited StatesUnknown status
Retina Consultants of Hawaii, Inc.
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‘AieaUnited StatesUnknown status
Vision Research Center Eye Associates of New Mexico
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AlbuquerqueUnited StatesUnknown status
Win Retina - Arcadia
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ArcadiaUnited StatesUnknown status
Austin Retina Associates
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AustinUnited StatesUnknown status
California Retina Consultants
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BakersfieldUnited StatesUnknown status
Retina Associates of Cleveland - Beachwood
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BeachwoodUnited StatesUnknown status
Retina Consultants of Texas
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BeaumontUnited StatesUnknown status
Retina Consultants of Texas - Houston
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BellaireUnited StatesUnknown status
Pacific Northwest Retina
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BellevueUnited StatesUnknown status
Mid Atlantic Retina
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BethlehemUnited StatesUnknown status
Retina Specialists of Beverly Hills
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Beverly HillsUnited StatesUnknown status
Opthalmic Consultants of Boston
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BostonUnited StatesUnknown status
Cincinnati Eye Institute
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CincinnatiUnited StatesUnknown status
Retina Consultants of Southern Colorado
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Colorado SpringsUnited StatesUnknown status
Texas Retina Associates - Dallas
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DallasUnited StatesUnknown status
Advanced Research LLC
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Deerfield BeachUnited StatesUnknown status
Retina Consultants of Minnesota
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EdinaUnited StatesUnknown status
Southwest Retina Consultants
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El PasoUnited StatesUnknown status
Mid Atlantic Retina Specialists - Hagerstown
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HagerstownUnited StatesUnknown status
Cumberland Valley Retina Consultants-Ophthalmology
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HagerstownUnited StatesUnknown status
Salehi Retina Institute, dba Retina Associates of Southern California
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Huntington BeachUnited StatesUnknown status
Florida Retina Institute - Jacksonville
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JacksonvilleUnited StatesUnknown status
Retina Consultants of Texas
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KatyUnited StatesUnknown status
Charleston Neuroscience Institute LLC
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LadsonUnited StatesUnknown status
Florida Retina Consultants
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LakelandUnited StatesUnknown status
University Retina and Macula Associates PC - Lemont
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LemontUnited StatesUnknown status
South Coast Retina Center
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Long BeachUnited StatesUnknown status
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute
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LongmontUnited StatesUnknown status
Georgia Retina
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MariettaUnited StatesUnknown status
Tennessee Retina, PC
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NashvilleUnited StatesUnknown status
Illinois Retina Associates
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Oak ParkUnited StatesUnknown status
Florida Retina Institute - Orlando
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OrlandoUnited StatesUnknown status
California Eye Specialists Medical Group, Inc.
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PasadenaUnited StatesUnknown status
Retina Speciality Institute - Pensacola, Florida
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PensacolaUnited StatesUnknown status
Eye Associates of Pinellas
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Pinellas ParkUnited StatesUnknown status
EyeHealth Northwest
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PortlandUnited StatesUnknown status
Retina Consultants of Southern California
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RedlandsUnited StatesUnknown status
Austin Retina Associates
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Round RockUnited StatesUnknown status
VRMG Inc
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SacramentoUnited StatesUnknown status
Retina Consultants of Texas
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San AntonioUnited StatesUnknown status
Retina Consultants of Texas Brown Retina Institute
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San AntonioUnited StatesUnknown status
Sewickley Eye Group
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SewickleyUnited StatesUnknown status
Deep Blue Retina Clinical Research PLLC
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SouthavenUnited StatesUnknown status
Retina Vitreous Associates of Florida - Saint Petersburg
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St. PetersburgUnited StatesUnknown status
Retina Vitreous Associates of Florida
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TampaUnited StatesUnknown status
Retina Consultants Texas
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The WoodlandsUnited StatesUnknown status
Tulsa Retina Consultants
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TulsaUnited StatesUnknown status
North Carolina Retina Associates
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Wake ForestUnited StatesUnknown status
Retina Group of New England
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WaterfordUnited StatesUnknown status
Vitreoretinal Consultants of NY - Westbury
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WestburyUnited StatesUnknown status
Palmetto Retina Center
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West ColumbiaUnited StatesUnknown status
Center for Retina and Macular Disease
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Winter HavenUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.