Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

One-Shot hope for blinding eye disease? new trial underway

NCT ID NCT07215234

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 21, 2026 · Updated 4 times

Summary

This study tests a single injection into the eye of a new drug (SAR446597) for people with geographic atrophy, a progressive form of age-related macular degeneration that causes vision loss. About 104 participants aged 60 and older will be followed for 2 years, with an optional 3-year extension, to check safety and whether the treatment slows the growth of the damaged area. The goal is to control the disease, not cure it, as ongoing management is expected.

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 104 people

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

Started

Oct 2025

Expected to finish

Jul 2032

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

60 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.

Inclusion Criteria: * 60 years old or above * Participants with diagnosis of GA secondary to age-related macular degeneration (AMD) * Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200 * Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II Exclusion Criteria: * GA in the study eye caused by a disease different than AMD * Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye * Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments * Current or history of systemic complement targeting treatment in the past 12 months * Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye * History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye * History of active ocular infection in the study eye in 6 months prior to screening * Presence of active ocular or periocular infections * Active uncontrolled glaucoma in the study eye * History of uveitis or scleritis in either eye * Previous gene therapy in either eye * 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 patient's potential participation in a clinical trial.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Geographic atrophy are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    31 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Associated Retina Consultants - Peoria- Site Number : 8400011

    RECRUITING

    Peoria, Arizona, 85381, United States

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

    RECRUITING

    Austin, Texas, 78750, United States

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400016

    RECRUITING

    Ladson, South Carolina, 29456, United States

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400046

    RECRUITING

    Ladson, South Carolina, 29456, United States

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

    RECRUITING

    Hagerstown, Maryland, 21740, United States

  • Erie Retina Research- Site Number : 8400035

    RECRUITING

    Erie, Pennsylvania, 16505, United States

  • Investigational Site Number : 0360001

    RECRUITING

    East Melbourne, Victoria, 3002, Australia

  • Investigational Site Number : 0360002

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Investigational Site Number : 0360003

    RECRUITING

    Sydney, New South Wales, 2000, Australia

  • Macula Retina Vitreous Center - Torrance- Site Number : 8400053

    RECRUITING

    Torrance, California, 90503, United States

  • Mid Atlantic Retina - Bethlehem- Site Number : 8400031

    RECRUITING

    Bethlehem, Pennsylvania, 18017-9412, United States

  • North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059

    RECRUITING

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

  • Oregon Retina- Site Number : 8400017

    RECRUITING

    Eugene, Oregon, 97401, United States

  • Retina Center of Texas (RCT) - Southlake- Site Number : 8400048

    RECRUITING

    Southlake, Texas, 76092, United States

  • Retina Consultants of Austin- Site Number : 8400015

    RECRUITING

    Austin, Texas, 78705, United States

  • Retina Consultants of Texas - Bellaire- Site Number : 8400019

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Retina Foundation of the Southwest- Site Number : 8400001

    RECRUITING

    Dallas, Texas, 75231, United States

  • Retina Macula Institute of Arizona- Site Number : 8400028

    RECRUITING

    Scottsdale, Arizona, 85255, United States

  • Retina Specialist- Site Number : 8400055

    RECRUITING

    Towson, Maryland, 21204, United States

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

    RECRUITING

    St. Petersburg, Florida, 33711, United States

  • Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054

    RECRUITING

    Sacramento, California, 95825, United States

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

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Sierra Eye Associates- Site Number : 8400021

    RECRUITING

    Reno, Nevada, 89502, United States

  • Southeast Retina Center- Site Number : 8400044

    RECRUITING

    Augusta, Georgia, 30909, United States

  • Texas Retina Associates - Arlington- Site Number : 8400056

    RECRUITING

    Arlington, Texas, 76012, United States

  • Texas Retina Associates - Dallas- Site Number : 8400006

    RECRUITING

    Dallas, Texas, 75231, United States

  • The Retina Group of Washington - Chevy Chase- Site Number : 8400009

    RECRUITING

    Chevy Chase, Maryland, 20815, United States

  • The Retina Partners- Site Number : 8400040

    RECRUITING

    Encino, California, 91436, United States

  • University Retina - Lemont- Site Number : 8400005

    RECRUITING

    Lemont, Illinois, 60439, United States

  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004

    RECRUITING

    Gainesville, Florida, 32607, United States

More trials for these conditions

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