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NCT06491914 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, sponsored by Regeneron Pharmaceuticals.
- Active
- Registry status
- Phase 3
- Development phase
- 1,118
- Enrollment target
- 20
- Study locations
NCT06491914 is a Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration that is active but no longer recruiting, run by Regeneron Pharmaceuticals. The registered enrollment target is 1,118 participants, below the 3,777-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (70% lower). The trial reports 20 study locations across 4 states.
The verdict
NCT06491914, a Phase 3 study of Diabetic Macular Edema and Neovascular Age-related Macular Degeneration, is active but no longer recruiting, sponsored by Regeneron Pharmaceuticals.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,118 participants
- Enrollment target
- 20
- Study locations
Study 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.
Conditions Studied
Interventions
- DRUG Aflibercept 8 mg
Study Locations (20)
Florida
- Advanced Research, LLC - Deerfield Beach
- Florida Retina Institute - Jacksonville - Jacksonville
- Florida Retina Consultants - Lakeland
- Florida Retina Institute - Orlando - Orlando
- Retina Speciality Institute - Pensacola, Florida - Pensacola
- Eye Associates of Pinellas - Pinellas Park
- Retina Vitreous Associates of Florida Saint Petersburg - St. Petersburg
- Retina Vitreous Associates of Florida - Tampa
- Center for Retina and Macular Disease - Winter Haven
California
- Win Retina - Arcadia - Arcadia
- California Retina Consultants - Bakersfield
- Retina Specialists of Beverly Hills - Beverly Hills
- Salehi Retina Institute dba Retina Associates of Southern California - Huntington Beach
- South Coast Retina Center - Long Beach
- California Eye Specialists Medical Group, Inc. - Pasadena
- Retina Consultants of Southern California - Redlands
- Vrmg Inc - Sacramento
Colorado
- Retina Consultants of Southern Colorado - Colorado Springs
- Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute - Longmont
Connecticut
- Retina Group of New England - Waterford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,118 participants |
| Start Date | 2024-07-24 |
| Est. Completion | 2027-01-07 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06491914
The ClinicalTrials.gov registry entry for NCT06491914 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 1,118 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,777-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (70% lower). The listed sponsor is Regeneron Pharmaceuticals, which has 280 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Diabetic Macular Edema appearing as the primary indexed condition, and to 1 intervention - of which Aflibercept 8 mg is the first listed.
NCT06491914 reports 20 study locations spanning 4 distinct geographic areas - top geographies include Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT06491914 about?
NCT06491914 is a clinical study titled "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)". 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...
What is the current status of trial NCT06491914?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 1,118 participants. The study started on 2024-07-24. Estimated completion is 2027-01-07.
What conditions does trial NCT06491914 study?
This clinical trial studies the following conditions: Diabetic Macular Edema, Neovascular Age-related Macular Degeneration.
What interventions are being tested in trial NCT06491914?
The interventions under investigation include: Aflibercept 8 mg (DRUG).
Who is sponsoring clinical trial NCT06491914?
This trial is sponsored by Regeneron Pharmaceuticals, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06491914 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.