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
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