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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)
Sponsor: Regeneron Pharmaceuticals
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1118
Start Date
2024-07-24
Completion Date
2027-01-07
Last Updated
2025-10-15
Healthy Volunteers
No
Interventions
Aflibercept 8 mg
Administered by intravitreal (IVT) injection
Locations (54)
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
St. 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
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
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
Austin, Texas, United States
Retina Consultants of Texas
Beaumont, 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
Retina Consultants of Texas
Katy, Texas, United States
Austin Retina Associates
Round Rock, Texas, United States
Retina Consultants of Texas
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
Pacific Northwest Retina
Bellevue, Washington, United States
Emanuelli Research and Development Center
Arecibo, Puerto Rico