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
- Diseases
- Macular degeneration, Diabetic eye disease
- 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
Sites (54)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Emanuelli Research and Development Center Coordinator of this site? Confirm its status | Arecibo | Puerto Rico | Unknown status |
| Retina Research Institute of Texas Coordinator of this site? Confirm its status | Abilene | United States | Unknown status |
| Retina Consultants of Hawaii, Inc. Coordinator of this site? Confirm its status | ‘Aiea | United States | Unknown status |
| Vision Research Center Eye Associates of New Mexico Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| Win Retina - Arcadia Coordinator of this site? Confirm its status | Arcadia | United States | Unknown status |
| Austin Retina Associates Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| California Retina Consultants Coordinator of this site? Confirm its status | Bakersfield | United States | Unknown status |
| Retina Associates of Cleveland - Beachwood Coordinator of this site? Confirm its status | Beachwood | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Beaumont | United States | Unknown status |
| Retina Consultants of Texas - Houston Coordinator of this site? Confirm its status | Bellaire | United States | Unknown status |
| Pacific Northwest Retina Coordinator of this site? Confirm its status | Bellevue | United States | Unknown status |
| Mid Atlantic Retina Coordinator of this site? Confirm its status | Bethlehem | United States | Unknown status |
| Retina Specialists of Beverly Hills Coordinator of this site? Confirm its status | Beverly Hills | United States | Unknown status |
| Opthalmic Consultants of Boston Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cincinnati Eye Institute Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Retina Consultants of Southern Colorado Coordinator of this site? Confirm its status | Colorado Springs | United States | Unknown status |
| Texas Retina Associates - Dallas Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| Advanced Research LLC Coordinator of this site? Confirm its status | Deerfield Beach | United States | Unknown status |
| Retina Consultants of Minnesota Coordinator of this site? Confirm its status | Edina | United States | Unknown status |
| Southwest Retina Consultants Coordinator of this site? Confirm its status | El Paso | United States | Unknown status |
| Mid Atlantic Retina Specialists - Hagerstown Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Cumberland Valley Retina Consultants-Ophthalmology Coordinator of this site? Confirm its status | Hagerstown | United States | Unknown status |
| Salehi Retina Institute, dba Retina Associates of Southern California Coordinator of this site? Confirm its status | Huntington Beach | United States | Unknown status |
| Florida Retina Institute - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | Katy | United States | Unknown status |
| Charleston Neuroscience Institute LLC Coordinator of this site? Confirm its status | Ladson | United States | Unknown status |
| Florida Retina Consultants Coordinator of this site? Confirm its status | Lakeland | United States | Unknown status |
| University Retina and Macula Associates PC - Lemont Coordinator of this site? Confirm its status | Lemont | United States | Unknown status |
| South Coast Retina Center Coordinator of this site? Confirm its status | Long Beach | United States | Unknown status |
| Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute Coordinator of this site? Confirm its status | Longmont | United States | Unknown status |
| Georgia Retina Coordinator of this site? Confirm its status | Marietta | United States | Unknown status |
| Tennessee Retina, PC Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Illinois Retina Associates Coordinator of this site? Confirm its status | Oak Park | United States | Unknown status |
| Florida Retina Institute - Orlando Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| California Eye Specialists Medical Group, Inc. Coordinator of this site? Confirm its status | Pasadena | United States | Unknown status |
| Retina Speciality Institute - Pensacola, Florida Coordinator of this site? Confirm its status | Pensacola | United States | Unknown status |
| Eye Associates of Pinellas Coordinator of this site? Confirm its status | Pinellas Park | United States | Unknown status |
| EyeHealth Northwest Coordinator of this site? Confirm its status | Portland | United States | Unknown status |
| Retina Consultants of Southern California Coordinator of this site? Confirm its status | Redlands | United States | Unknown status |
| Austin Retina Associates Coordinator of this site? Confirm its status | Round Rock | United States | Unknown status |
| VRMG Inc Coordinator of this site? Confirm its status | Sacramento | United States | Unknown status |
| Retina Consultants of Texas Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Retina Consultants of Texas Brown Retina Institute Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Sewickley Eye Group Coordinator of this site? Confirm its status | Sewickley | United States | Unknown status |
| Deep Blue Retina Clinical Research PLLC Coordinator of this site? Confirm its status | Southaven | United States | Unknown status |
| Retina Vitreous Associates of Florida - Saint Petersburg Coordinator of this site? Confirm its status | St. Petersburg | United States | Unknown status |
| Retina Vitreous Associates of Florida Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
| Retina Consultants Texas Coordinator of this site? Confirm its status | The Woodlands | United States | Unknown status |
| Tulsa Retina Consultants Coordinator of this site? Confirm its status | Tulsa | United States | Unknown status |
| North Carolina Retina Associates Coordinator of this site? Confirm its status | Wake Forest | United States | Unknown status |
| Retina Group of New England Coordinator of this site? Confirm its status | Waterford | United States | Unknown status |
| Vitreoretinal Consultants of NY - Westbury Coordinator of this site? Confirm its status | Westbury | United States | Unknown status |
| Palmetto Retina Center Coordinator of this site? Confirm its status | West Columbia | United States | Unknown status |
| Center for Retina and Macular Disease Coordinator of this site? Confirm its status | Winter Haven | United States | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.