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)
Running, not enrolling · Phase 3
Conditions studied: Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema
In brief
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.
Key facts
- Study ID
- NCT06491914
- Run by
- Regeneron Pharmaceuticals
- People needed
- 1118
- Starts
- 2024-07-24
- Expected to finish
- 2027-01-07
- Last updated by the study team
- 2025-10-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
- Win Retina - Arcadia — Arcadia, California, United States
Full record on ClinicalTrials.gov
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