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Higher-Dose eye injection shows promise for two leading causes of vision loss

NCT ID NCT06491914

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

This study tests a higher dose of the drug aflibercept (8 mg) given as an eye injection every 4 weeks to people with wet age-related macular degeneration (nAMD) or diabetic macular edema (DME). The goal is to see if this dosing schedule is safe and works well for those who have already been treated with similar medications. About 1,118 adults will take part, and researchers will track side effects and serious side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,126 people

The number who actually took part.

Started

Jul 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

diabetic macular edema wet macular degeneration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema Neovascular age-related macular degeneration

Contacts and locations

Locations

  • Advanced Research, LLC

    Deerfield Beach, Florida, 33064, United States

  • Austin Retina Associates

    Austin, Texas, 78705, United States

  • Austin Retina Associates

    Round Rock, Texas, 78681, United States

  • California Eye Specialists Medical Group, Inc.

    Pasadena, California, 91107, United States

  • California Retina Consultants

    Bakersfield, California, 93309, United States

  • Center for Retina and Macular Disease

    Winter Haven, Florida, 33880, United States

  • Charleston Neuroscience Institute LLC

    Ladson, South Carolina, 29456, United States

  • Cincinnati Eye Institute

    Cincinnati, Ohio, 45242, United States

  • Cumberland Valley Retina Consultants-Ophthalmology

    Hagerstown, Maryland, 21740, United States

  • Deep Blue Retina Clinical Research PLLC

    Southaven, Mississippi, 38671, United States

  • Emanuelli Research and Development Center

    Arecibo, 00612, Puerto Rico

  • Eye Associates of Pinellas

    Pinellas Park, Florida, 33782, United States

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

    Longmont, Colorado, 80503, United States

  • EyeHealth Northwest

    Portland, Oregon, 97225, United States

  • Florida Retina Consultants

    Lakeland, Florida, 33805, United States

  • Florida Retina Institute - Jacksonville

    Jacksonville, Florida, 32216, United States

  • Florida Retina Institute - Orlando

    Orlando, Florida, 32806, United States

  • Georgia Retina

    Marietta, Georgia, 30060, United States

  • Illinois Retina Associates

    Oak Park, Illinois, 60304, United States

  • Mid Atlantic Retina

    Bethlehem, Pennsylvania, 18017, United States

  • Mid Atlantic Retina Specialists Hagerstown

    Hagerstown, Maryland, 21740, United States

  • North Carolina Retina Associates

    Wake Forest, North Carolina, 27587, United States

  • Opthalmic Consultants of Boston

    Boston, Massachusetts, 02114, United States

  • Pacific Northwest Retina

    Bellevue, Washington, 98004, United States

  • Palmetto Retina Center

    West Columbia, South Carolina, 29169, United States

  • Retina Associates of Cleveland - Beachwood

    Beachwood, Ohio, 44122, United States

  • Retina Consultants Texas

    The Woodlands, Texas, 77384, United States

  • Retina Consultants of Hawaii, Inc.

    ‘Aiea, Hawaii, 96701, United States

  • Retina Consultants of Minnesota

    Edina, Minnesota, 55435, United States

  • Retina Consultants of Southern California

    Redlands, California, 92374, United States

  • Retina Consultants of Southern Colorado

    Colorado Springs, Colorado, 80909, United States

  • Retina Consultants of Texas

    Beaumont, Texas, 77707, United States

  • Retina Consultants of Texas

    Katy, Texas, 77494, United States

  • Retina Consultants of Texas

    San Antonio, Texas, 78240, United States

  • Retina Consultants of Texas - Houston

    Bellaire, Texas, 77401, United States

  • Retina Consultants of Texas Brown Retina Institute

    San Antonio, Texas, 78251, United States

  • Retina Group of New England

    Waterford, Connecticut, 06385, United States

  • Retina Research Institute of Texas

    Abilene, Texas, 79606, United States

  • Retina Specialists of Beverly Hills

    Beverly Hills, California, 90212, United States

  • Retina Speciality Institute - Pensacola, Florida

    Pensacola, Florida, 32503, United States

  • Retina Vitreous Associates of Florida

    Tampa, Florida, 33617, United States

  • Retina Vitreous Associates of Florida Saint Petersburg

    St. Petersburg, Florida, 33711, United States

  • Salehi Retina Institute dba Retina Associates of Southern California

    Huntington Beach, California, 92647, United States

  • Sewickley Eye Group

    Sewickley, Pennsylvania, 15143, United States

  • South Coast Retina Center

    Long Beach, California, 90807, United States

  • Southwest Retina Consultants

    El Paso, Texas, 79902, United States

  • Tennessee Retina, PC

    Nashville, Tennessee, 37203, United States

  • Texas Retina Associates - Dallas

    Dallas, Texas, 75231, United States

  • Tulsa Retina Consultants

    Tulsa, Oklahoma, 74114, United States

  • University Retina and Macula Associates PC - Lemont

    Lemont, Illinois, 60439, United States

  • Vision Research Center Eye Associates of New Mexico

    Albuquerque, New Mexico, 87109, United States

  • Vitreoretinal Consultants of NY - Westbury

    Westbury, New York, 11590, United States

  • Vrmg Inc

    Sacramento, California, 95825, United States

  • Win Retina - Arcadia

    Arcadia, California, 91006, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.