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)
- Conditions
- Diabetic Macular EdemaNeovascular Age-Related Macular Degeneration
- Interventions
- 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
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1118
Not provided
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
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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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