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Single shot could replace monthly eye injections for wet AMD

NCT ID NCT06660667

Disease control Sponsor: Sanofi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 17, 2026 · Updated 6 times

Summary

This study tests a new drug called SAR402663, given as a single injection into the eye, for people with wet age-related macular degeneration (AMD). The goal is to see if one dose can safely control the disease and reduce the need for frequent anti-VEGF injections. About 66 participants aged 50–90 will be followed for up to 5 years.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
SAR402663 (a biologic drug given as a one-time injection into the eye)
What this could lead to
If successful, this could mean fewer eye injections for people with wet AMD, potentially controlling the disease with a single dose instead of repeated treatments.
What could go wrong
This is an early-phase trial with only 66 participants, so safety and effectiveness are not yet proven. The one-time injection may not work for everyone, and there are risks like eye inflammation or infection.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 66 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Jun 2031

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

50 to 90 years

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.

Inclusion Criteria: * Between 50 and 90 years of age * Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD) * Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200 * Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye * Demonstrated a response to anti-VEGF treatment Exclusion Criteria: * Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments * History of active ocular infection in the study eye in 6 months prior to screening * Active uncontrolled glaucoma in the study eye * History of uveitis in either eye * Current use of ocular corticosteroids in the study eye * Previous gene therapy * Any significant poorly controlled illness that would preclude study compliance and follow up The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

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Conditions

The condition(s) this trial relates to.

wet macular degeneration

As listed by the trial registrant

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

Neovascular age-related macular degeneration

Contacts and locations

Locations

  • Associated Retina Consultants - Phoenix- Site Number : 8400011

    Phoenix, Arizona, 85020, United States

  • Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007

    Austin, Texas, 78750, United States

  • Austin Research Center for Retina- Site Number : 8400015

    Austin, Texas, 78705, United States

  • California Retina Consultants - Bakersfield- Site Number : 8400001

    Bakersfield, California, 93309, United States

  • Charles Retina Institution- Site Number : 8400018

    Germantown, Tennessee, 38138, United States

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400016

    Ladson, South Carolina, 29456, United States

  • Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003

    Hagerstown, Maryland, 21740, United States

  • Investigational Site Number : 8260024

    London, Westminster, W1G 7LB, United Kingdom

  • Investigational Site Number : 8260027

    Liverpool, L7 8XP, United Kingdom

  • Medical Center Ophthalmology Associates- Site Number : 8400030

    San Antonio, Texas, 78240, United States

  • Mid Atlantic Retina- Site Number : 8400032

    Bethlehem, Pennsylvania, 18017-9412, United States

  • North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400033

    Wake Forest, North Carolina, 27587-3803, United States

  • Ophthalmic Consultants of Boston - Boston- Site Number : 8400009

    Boston, Massachusetts, 02114, United States

  • Oregon Retina- Site Number : 8400017

    Eugene, Oregon, 97401, United States

  • Retina Consultants of Texas - The Woodlands- Site Number : 8400019

    The Woodlands, Texas, 77384, United States

  • Retina Macula Institute of Arizona- Site Number : 8400028

    Scottsdale, Arizona, 85255, United States

  • Retina Research Institute of Texas- Site Number : 8400008

    Abilene, Texas, 79606, United States

  • Retina Specialist- Site Number : 8400020

    Towson, Maryland, 21204, United States

  • Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002

    St. Petersburg, Florida, 33711, United States

  • Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023

    Beverly Hills, California, 90211, United States

  • Retinal Consultants of Texas - San Antonio- Site Number : 8400012

    San Antonio, Texas, 78240, United States

  • Sierra Eye Associates- Site Number : 8400021

    Reno, Nevada, 89502, United States

  • Southeast Retina Center- Site Number : 8400010

    Augusta, Georgia, 30909, United States

  • Texas Retina Associates - Dallas- Site Number : 8400006

    Dallas, Texas, 75231, United States

  • University Retina - Lemont- Site Number : 8400005

    Lemont, Illinois, 60439, United States

  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004

    Gainesville, Florida, 32607, United States

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