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)

Phase 3

Active, not recruiting

• Conditions: Diabetic Macular Edema; Neovascular Age-Related Macular Degeneration
• Interventions: Drug: Aflibercept 8 mg

• Registration Number: NCT06491914
• Lead Sponsor: Regeneron Pharmaceuticals

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-01
• Study First Posted: 2024-07-09
• Study Start: 2024-07-24
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-08-21
• Study Completion: 2027-01-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1118

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Aflibercept 8 mg	Aflibercept 8 mg	Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications

Primary Outcome Measures

Name	Time	Method
Occurrence of serious TEAEs	Through week 24
Occurrence of treatment-emergent adverse events (TEAEs)	Through week 24

Trial Locations

Locations (55)

Win Retina - Arcadia; 🇺🇸 Arcadia, California, United States

California Retina Consultants; 🇺🇸 Bakersfield, California, United States

Retina Specialists of Beverly Hills; 🇺🇸 Beverly Hills, California, United States

Salehi Retina Institute dba Retina Associates of Southern California; 🇺🇸 Huntington Beach, California, United States

South Coast Retina Center; 🇺🇸 Long Beach, California, United States

California Eye Specialists Medical Group, Inc.; 🇺🇸 Pasadena, California, United States

Retina Consultants of Southern California; 🇺🇸 Redlands, California, United States

Vrmg Inc; 🇺🇸 Sacramento, California, United States

Retina Consultants of Southern Colorado; 🇺🇸 Colorado Springs, Colorado, United States

Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute; 🇺🇸 Longmont, Colorado, United States

Retina Group of New England; 🇺🇸 Waterford, Connecticut, United States

Advanced Research, LLC; 🇺🇸 Deerfield Beach, Florida, United States

Florida Retina Institute - Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Florida Retina Consultants; 🇺🇸 Lakeland, Florida, United States

Florida Retina Institute - Orlando; 🇺🇸 Orlando, Florida, United States

Retina Speciality Institute - Pensacola, Florida; 🇺🇸 Pensacola, Florida, United States

Eye Associates of Pinellas; 🇺🇸 Pinellas Park, Florida, United States

Retina Vitreous Associates of Florida Saint Petersburg; 🇺🇸 Saint Petersburg, Florida, United States

Retina Vitreous Associates of Florida; 🇺🇸 Tampa, Florida, United States

Center for Retina and Macular Disease; 🇺🇸 Winter Haven, Florida, United States

Georgia Retina; 🇺🇸 Marietta, Georgia, United States

Retina Consultants of Hawaii, Inc.; 🇺🇸 'Aiea, Hawaii, United States

University Retina and Macula Associates PC - Lemont; 🇺🇸 Lemont, Illinois, United States

Illinois Retina Associates; 🇺🇸 Oak Park, Illinois, United States

Springfield Clinic Main Campus East; 🇺🇸 Springfield, Illinois, United States

Cumberland Valley Retina Consultants-Ophthalmology; 🇺🇸 Hagerstown, Maryland, United States

Mid Atlantic Retina Specialists Hagerstown; 🇺🇸 Hagerstown, Maryland, United States

Opthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Retina Consultants of Minnesota; 🇺🇸 Edina, Minnesota, United States

Deep Blue Retina Clinical Research PLLC; 🇺🇸 Southaven, Mississippi, United States

NJ Retina; 🇺🇸 Edison, New Jersey, United States

Vision Research Center Eye Associates of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Vitreoretinal Consultants of NY - Westbury; 🇺🇸 Westbury, New York, United States

North Carolina Retina Associates; 🇺🇸 Wake Forest, North Carolina, United States

Retina Associates of Cleveland - Beachwood; 🇺🇸 Beachwood, Ohio, United States

Cincinnati Eye Institute; 🇺🇸 Cincinnati, Ohio, United States

Tulsa Retina Consultants; 🇺🇸 Tulsa, Oklahoma, United States

EyeHealth Northwest; 🇺🇸 Portland, Oregon, United States

Mid Atlantic Retina; 🇺🇸 Bethlehem, Pennsylvania, United States

Sewickley Eye Group; 🇺🇸 Sewickley, Pennsylvania, United States

Charleston Neuroscience Institute LLC; 🇺🇸 Ladson, South Carolina, United States

Palmetto Retina Center; 🇺🇸 West Columbia, South Carolina, United States

Tennessee Retina, PC; 🇺🇸 Nashville, Tennessee, United States

Retina Research Institute of Texas; 🇺🇸 Abilene, Texas, United States

Austin Retina Associates; 🇺🇸 Round Rock, Texas, United States

Retina Consultants of Texas; 🇺🇸 San Antonio, Texas, United States

Retina Consultants of Texas - Houston; 🇺🇸 Bellaire, Texas, United States

Texas Retina Associates - Dallas; 🇺🇸 Dallas, Texas, United States

Southwest Retina Consultants; 🇺🇸 El Paso, Texas, United States

San Antonio Eye Center - Downtown Clinic; 🇺🇸 San Antonio, Texas, United States

Retina Consultants of Texas Brown Retina Institute; 🇺🇸 San Antonio, Texas, United States

Retina Consultants Texas; 🇺🇸 The Woodlands, Texas, United States

Retina Group of Washington; 🇺🇸 Fairfax, Virginia, United States

Pacific Northwest Retina; 🇺🇸 Bellevue, Washington, United States

Emanuelli Research and Development Center; 🇵🇷 Arecibo, Puerto Rico