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 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: VGFTe-HD-OD-2444
• Study Type: interventional
• Target: 1,118
• Locations: 2 countries
• Sites: 54

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.

Conditions

Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (2)

• Occurrence of treatment-emergent adverse events (TEAEs)

  Through week 24

• Occurrence of serious TEAEs

  Through week 24

Study Arms (1)

Aflibercept 8 mg

EXPERIMENTAL

Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications

Drug: Aflibercept 8 mg

Interventions

Aflibercept 8 mg DRUG

Administered by intravitreal (IVT) injection

Also known as: EYLEA®HD, BAY86-5321

Aflibercept 8 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥50 years of age
• History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.
• ≥18 years of age
• 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
• Previously treated with ≥3 anti-VEGF IVT injections in the study eye in the 5 months (\~150 days) prior to visit 1

You may not qualify if:

• Evidence of CNV due to any cause other than nAMD in either eye
• Evidence of macular edema due to any other cause other than diabetes mellitus in the study eye
• Active proliferative diabetic retinopathy (DR) in the study eye

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (54)

Win Retina - Arcadia

Arcadia, California, 91006, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina Specialists of Beverly Hills

Beverly Hills, California, 90212, United States

Location

Salehi Retina Institute dba Retina Associates of Southern California

Huntington Beach, California, 92647, United States

Location

South Coast Retina Center

Long Beach, California, 90807, United States

Location

California Eye Specialists Medical Group, Inc.

Pasadena, California, 91107, United States

Location

Retina Consultants of Southern California

Redlands, California, 92374, United States

Location

Vrmg Inc

Sacramento, California, 95825, United States

Location

Retina Consultants of Southern Colorado

Colorado Springs, Colorado, 80909, United States

Location

Eye care Center of Northern Colorado doing business as Advanced Vision Research Institute

Longmont, Colorado, 80503, United States

Location

Retina Group of New England

Waterford, Connecticut, 06385, United States

Location

Advanced Research, LLC

Deerfield Beach, Florida, 33064, United States

Location

Florida Retina Institute - Jacksonville

Jacksonville, Florida, 32216, United States

Location

Florida Retina Consultants

Lakeland, Florida, 33805, United States

Location

Florida Retina Institute - Orlando

Orlando, Florida, 32806, United States

Location

Retina Speciality Institute - Pensacola, Florida

Pensacola, Florida, 32503, United States

Location

Eye Associates of Pinellas

Pinellas Park, Florida, 33782, United States

Location

Retina Vitreous Associates of Florida Saint Petersburg

St. Petersburg, Florida, 33711, United States

Location

Retina Vitreous Associates of Florida

Tampa, Florida, 33617, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Georgia Retina

Marietta, Georgia, 30060, United States

Location

Retina Consultants of Hawaii, Inc.

‘Aiea, Hawaii, 96701, United States

Location

University Retina and Macula Associates PC - Lemont

Lemont, Illinois, 60439, United States

Location

Illinois Retina Associates

Oak Park, Illinois, 60304, United States

Location

Cumberland Valley Retina Consultants-Ophthalmology

Hagerstown, Maryland, 21740, United States

Location

Mid Atlantic Retina Specialists Hagerstown

Hagerstown, Maryland, 21740, United States

Location

Opthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Retina Consultants of Minnesota

Edina, Minnesota, 55435, United States

Location

Deep Blue Retina Clinical Research PLLC

Southaven, Mississippi, 38671, United States

Location

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Vitreoretinal Consultants of NY - Westbury

Westbury, New York, 11590, United States

Location

North Carolina Retina Associates

Wake Forest, North Carolina, 27587, United States

Location

Retina Associates of Cleveland - Beachwood

Beachwood, Ohio, 44122, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Tulsa Retina Consultants

Tulsa, Oklahoma, 74114, United States

Location

EyeHealth Northwest

Portland, Oregon, 97225, United States

Location

Mid Atlantic Retina

Bethlehem, Pennsylvania, 18017, United States

Location

Sewickley Eye Group

Sewickley, Pennsylvania, 15143, United States

Location

Charleston Neuroscience Institute LLC

Ladson, South Carolina, 29456, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Austin Retina Associates

Austin, Texas, 78705, United States

Location

Retina Consultants of Texas

Beaumont, Texas, 77707, United States

Location

Retina Consultants of Texas - Houston

Bellaire, Texas, 77401, United States

Location

Texas Retina Associates - Dallas

Dallas, Texas, 75231, United States

Location

Southwest Retina Consultants

El Paso, Texas, 79902, United States

Location

Retina Consultants of Texas

Katy, Texas, 77494, United States

Location

Austin Retina Associates

Round Rock, Texas, 78681, United States

Location

Retina Consultants of Texas

San Antonio, Texas, 78240, United States

Location

Retina Consultants of Texas Brown Retina Institute

San Antonio, Texas, 78251, United States

Location

Retina Consultants Texas

The Woodlands, Texas, 77384, United States

Location

Pacific Northwest Retina

Bellevue, Washington, 98004, United States

Location

Emanuelli Research and Development Center

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2024
• First Posted: July 9, 2024
• Study Start: July 24, 2024
• Primary Completion: August 26, 2025
• Study Completion (Estimated): January 7, 2027
• Last Updated: October 15, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued developed of the product for all indications on or after April 2020 and has no plans for future development * made results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy.
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

PR (1); US (53)