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)

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified September 2025 by Regeneron Pharmaceuticals
Sponsor
Regeneron Pharmaceuticals
Information Provided by (Responsible Party)
Regeneron Pharmaceuticals
Clinicaltrials.gov Identifier
NCT06491914
Other Study ID Numbers:
VGFTe-HD-OD-2444
First Submitted
June 30, 2024
First Posted
July 8, 2024
Last Update Posted
October 14, 2025
Last Verified
September 2025

ClinicalTrials.gov processed this data on October 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Neovascular Age-Related Macular DegenerationDiabetic Macular Edema
Drug: Aflibercept 8 mg

Study Design

Study TypeInterventional
Actual Enrollment1118 participants
Design AllocationN/A
Interventional ModelSingle Group Assignment
MaskingNone (Open Label)
Primary PurposeTreatment
Official TitleA Phase 3b Single-Arm Study of Aflibercept 8 mg in Participants With Neovascular Age-Related Macular Degeneration (nAMD) or Diabetic Macular Edema (DME)
Study Start DateJuly 23, 2024
Actual Primary Completion DateAugust 25, 2025
Actual Study Completion Date8mos 2w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
Aflibercept 8 mg
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications
Drug: Aflibercept 8 mg
Administered by intravitreal (IVT) injection

Outcome Measures

Primary Outcome Measures
  1. Occurrence of treatment-emergent adverse events (TEAEs)
  2. Occurrence of serious TEAEs

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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
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.

Contacts and Locations

Sponsors and CollaboratorsRegeneron Pharmaceuticals
Locations
Win Retina - Arcadia | Arcadia California, United States, 91006California Retina Consultants | Bakersfield California, United States, 93309Retina Specialists of Beverly Hills | Beverly Hills California, United States, 90212Salehi Retina Institute dba Retina Associates of Southern California | Huntington Beach California, United States, 92647South Coast Retina Center | Long Beach California, United States, 90807California Eye Specialists Medical Group, Inc. | Pasadena California, United States, 91107Retina Consultants of Southern California | Redlands California, United States, 92374Vrmg Inc | Sacramento California, United States, 95825Retina Consultants of Southern Colorado | Colorado Springs Colorado, United States, 80909Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute | Longmont Colorado, United States, 80503Retina Group of New England | Waterford Connecticut, United States, 06385Advanced Research, LLC | Deerfield Beach Florida, United States, 33064Florida Retina Institute - Jacksonville | Jacksonville Florida, United States, 32216Florida Retina Consultants | Lakeland Florida, United States, 33805Florida Retina Institute - Orlando | Orlando Florida, United States, 32806Retina Speciality Institute - Pensacola, Florida | Pensacola Florida, United States, 32503Eye Associates of Pinellas | Pinellas Park Florida, United States, 33782Retina Vitreous Associates of Florida Saint Petersburg | St. Petersburg Florida, United States, 33711Retina Vitreous Associates of Florida | Tampa Florida, United States, 33617Center for Retina and Macular Disease | Winter Haven Florida, United States, 33880Georgia Retina | Marietta Georgia, United States, 30060Retina Consultants of Hawaii, Inc. | ‘Aiea Hawaii, United States, 96701University Retina and Macula Associates PC - Lemont | Lemont Illinois, United States, 60439Illinois Retina Associates | Oak Park Illinois, United States, 60304Cumberland Valley Retina Consultants-Ophthalmology | Hagerstown Maryland, United States, 21740Mid Atlantic Retina Specialists Hagerstown | Hagerstown Maryland, United States, 21740Opthalmic Consultants of Boston | Boston Massachusetts, United States, 02114Retina Consultants of Minnesota | Edina Minnesota, United States, 55435Deep Blue Retina Clinical Research PLLC | Southaven Mississippi, United States, 38671Vision Research Center Eye Associates of New Mexico | Albuquerque New Mexico, United States, 87109Vitreoretinal Consultants of NY - Westbury | Westbury New York, United States, 11590North Carolina Retina Associates | Wake Forest North Carolina, United States, 27587Retina Associates of Cleveland - Beachwood | Beachwood Ohio, United States, 44122Cincinnati Eye Institute | Cincinnati Ohio, United States, 45242Tulsa Retina Consultants | Tulsa Oklahoma, United States, 74114EyeHealth Northwest | Portland Oregon, United States, 97225Mid Atlantic Retina | Bethlehem Pennsylvania, United States, 18017Sewickley Eye Group | Sewickley Pennsylvania, United States, 15143Charleston Neuroscience Institute LLC | Ladson South Carolina, United States, 29456Palmetto Retina Center | West Columbia South Carolina, United States, 29169Tennessee Retina, PC | Nashville Tennessee, United States, 37203Retina Research Institute of Texas | Abilene Texas, United States, 79606Austin Retina Associates | Austin Texas, United States, 78705Retina Consultants of Texas | Beaumont Texas, United States, 77707Retina Consultants of Texas - Houston | Bellaire Texas, United States, 77401Texas Retina Associates - Dallas | Dallas Texas, United States, 75231Southwest Retina Consultants | El Paso Texas, United States, 79902Retina Consultants of Texas | Katy Texas, United States, 77494Austin Retina Associates | Round Rock Texas, United States, 78681Retina Consultants of Texas | San Antonio Texas, United States, 78240Retina Consultants of Texas Brown Retina Institute | San Antonio Texas, United States, 78251Retina Consultants Texas | The Woodlands Texas, United States, 77384Pacific Northwest Retina | Bellevue Washington, United States, 98004Emanuelli Research and Development Center | Arecibo , Puerto Rico, 00612
Investigators
Study Director: Clinical Trial Management, Regeneron Pharmaceuticals