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Clinical Trials in Mexico / NCT06491914
Active, not recruiting 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)

NCT06491914 · tracked via the Priya Life Science Mexico tracker
Phase
Phase 3
Started
2024-07-24
Last updated
2026-09-18

Condition(s) studied

Neovascular Age-Related Macular DegenerationDiabetic Macular Edema

Investigational drug(s) / intervention(s)

Aflibercept 8 mg →

Aflibercept 8 mg: Administered by intravitreal (IVT) injection

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria for Participants with nAMD: 1. ≥50 years of age 2. History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator. Key Inclusion Criteria for Participants with DME: 3. ≥18 years of age 4. History of DME with central involvement (in the central subfield on Spectral domain optical coherence tomography \[SD-OCT\]) in the study eye, requiring continued anti-VEGF treatment, as determined by the investigator Key Inclusion for All Participants: 5. Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (\~150 days) prior to visit 1 Key Exclusion Criteria for Participants with nAMD: 1. Evidence of CNV due to any cause other than nAMD in either eye Key Exclusion Criteria for Participants with DME: 2. Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye 3. Active proliferative diabetic retinopathy (DR) in the study eye NOTE: Other protocol defined inclusion / exclusion criteria apply.

Primary outcome measure(s)

Trial sites (54)

FacilityCityRegionStatus
Win Retina - Arcadia Arcadia California
California Retina Consultants Bakersfield California
Retina Specialists of Beverly Hills Beverly Hills California
Salehi Retina Institute dba Retina Associates of Southern California Huntington Beach California
South Coast Retina Center Long Beach California
California Eye Specialists Medical Group, Inc. Pasadena California
Retina Consultants of Southern California Redlands California
Vrmg Inc Sacramento California
Retina Consultants of Southern Colorado Colorado Springs Colorado
Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute Longmont Colorado
Retina Group of New England Waterford Connecticut
Advanced Research, LLC Deerfield Beach Florida
Florida Retina Institute - Jacksonville Jacksonville Florida
Florida Retina Consultants Lakeland Florida
Florida Retina Institute - Orlando Orlando Florida
Retina Speciality Institute - Pensacola, Florida Pensacola Florida
Eye Associates of Pinellas Pinellas Park Florida
Retina Vitreous Associates of Florida Saint Petersburg St. Petersburg Florida
Retina Vitreous Associates of Florida Tampa Florida
Center for Retina and Macular Disease Winter Haven Florida
Georgia Retina Marietta Georgia
Retina Consultants of Hawaii, Inc. ‘Aiea Hawaii
University Retina and Macula Associates PC - Lemont Lemont Illinois
Illinois Retina Associates Oak Park Illinois
Cumberland Valley Retina Consultants-Ophthalmology Hagerstown Maryland
Mid Atlantic Retina Specialists Hagerstown Hagerstown Maryland
Opthalmic Consultants of Boston Boston Massachusetts
Retina Consultants of Minnesota Edina Minnesota
Deep Blue Retina Clinical Research PLLC Southaven Mississippi
Vision Research Center Eye Associates of New Mexico Albuquerque New Mexico
Vitreoretinal Consultants of NY - Westbury Westbury New York
North Carolina Retina Associates Wake Forest North Carolina
Retina Associates of Cleveland - Beachwood Beachwood Ohio
Cincinnati Eye Institute Cincinnati Ohio
Tulsa Retina Consultants Tulsa Oklahoma
EyeHealth Northwest Portland Oregon
Mid Atlantic Retina Bethlehem Pennsylvania
Sewickley Eye Group Sewickley Pennsylvania
Charleston Neuroscience Institute LLC Ladson South Carolina
Palmetto Retina Center West Columbia South Carolina

+ 14 more sites — see the full list on the official registry below.

More Regeneron Pharmaceuticals trials in Mexico

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06491914 on ClinicalTrials.gov ↗ ← All trials in Mexico