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)
NCT ID: NCT06491914
Last Updated: 2025-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE3
1118 participants
INTERVENTIONAL
2024-07-24
2027-01-07
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study to Learn About the Blood Levels of Aflibercept When High-dose Aflibercept is Injected in Both Eyes of Participants With Diabetic Macular Edema or Neovascular Age-related Macular Degeneration
NCT06591598
Safety, Tolerability, and Efficacy of Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
NCT04126317
An Observational Study to Investigate the Use of Aflibercept 8 mg to Treat Adult Patients With Neovascular Age-Related Macular Degeneration (nAMD) and Diabetic Macular Edema (DME) in a Real-World Setting
NCT06398080
Study to Evaluate Efficacy of Aflibercept in Neovascular Age-related Macular Degeneration Patients Non Responders to Anti-Vascular Endothelial Growth Factor
NCT01896284
Study of the Efficacy and Safety of Intravitreal (IVT) Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (NPDR)
NCT02718326
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Aflibercept 8 mg
Participants previously treated with anti-vascular endothelial growth factor (anti-VEGF) medications
Aflibercept 8 mg
Administered by intravitreal (IVT) injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Aflibercept 8 mg
Administered by intravitreal (IVT) injection
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. History of choroidal neovascularization (CNV) lesions secondary to nAMD in the eye study, requiring continued anti-VEGF treatment, as determined by the investigator.
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
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
Mid Atlantic Retina Specialists Hagerstown
Hagerstown, Maryland, United States
Opthalmic Consultants of Boston
Boston, Massachusetts, United States
Retina Consultants of Minnesota
Edina, Minnesota, United States
Deep Blue Retina Clinical Research PLLC
Southaven, Mississippi, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, United States
Vitreoretinal Consultants of NY - Westbury
Westbury, New York, United States
North Carolina Retina Associates
Wake Forest, North Carolina, United States
Retina Associates of Cleveland - Beachwood
Beachwood, Ohio, United States
Cincinnati Eye Institute
Cincinnati, Ohio, United States
Tulsa Retina Consultants
Tulsa, Oklahoma, United States
EyeHealth Northwest
Portland, Oregon, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States
Sewickley Eye Group
Sewickley, Pennsylvania, United States
Charleston Neuroscience Institute LLC
Ladson, South Carolina, United States
Palmetto Retina Center
West Columbia, South Carolina, United States
Tennessee Retina, PC
Nashville, Tennessee, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Austin Retina Associates
Austin, Texas, United States
Retina Consultants of Texas
Beaumont, Texas, United States
Retina Consultants of Texas - Houston
Bellaire, Texas, United States
Texas Retina Associates - Dallas
Dallas, Texas, United States
Southwest Retina Consultants
El Paso, Texas, United States
Retina Consultants of Texas
Katy, Texas, United States
Austin Retina Associates
Round Rock, Texas, United States
Retina Consultants of Texas
San Antonio, Texas, United States
Retina Consultants of Texas Brown Retina Institute
San Antonio, Texas, United States
Retina Consultants Texas
The Woodlands, Texas, United States
Pacific Northwest Retina
Bellevue, Washington, United States
Emanuelli Research and Development Center
Arecibo, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VGFTe-HD-OD-2444
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.