One-Shot hope for blinding eye disease? new trial underway
NCT ID NCT07215234
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 104 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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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
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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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.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
31 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Associated Retina Consultants - Peoria- Site Number : 8400011
RECRUITINGPeoria, Arizona, 85381, United States
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Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
RECRUITINGAustin, Texas, 78750, United States
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Charleston Neuroscience Institute - Ladson- Site Number : 8400016
RECRUITINGLadson, South Carolina, 29456, United States
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Charleston Neuroscience Institute - Ladson- Site Number : 8400046
RECRUITINGLadson, South Carolina, 29456, United States
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Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
RECRUITINGHagerstown, Maryland, 21740, United States
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Erie Retina Research- Site Number : 8400035
RECRUITINGErie, Pennsylvania, 16505, United States
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Investigational Site Number : 0360001
RECRUITINGEast Melbourne, Victoria, 3002, Australia
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Investigational Site Number : 0360002
RECRUITINGAdelaide, South Australia, 5000, Australia
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Investigational Site Number : 0360003
RECRUITINGSydney, New South Wales, 2000, Australia
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Macula Retina Vitreous Center - Torrance- Site Number : 8400053
RECRUITINGTorrance, California, 90503, United States
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Mid Atlantic Retina - Bethlehem- Site Number : 8400031
RECRUITINGBethlehem, Pennsylvania, 18017-9412, United States
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North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059
RECRUITINGWake Forest, North Carolina, 27587-3803, United States
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Oregon Retina- Site Number : 8400017
RECRUITINGEugene, Oregon, 97401, United States
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Retina Center of Texas (RCT) - Southlake- Site Number : 8400048
RECRUITINGSouthlake, Texas, 76092, United States
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Retina Consultants of Austin- Site Number : 8400015
RECRUITINGAustin, Texas, 78705, United States
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Retina Consultants of Texas - Bellaire- Site Number : 8400019
RECRUITINGBellaire, Texas, 77401, United States
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Retina Foundation of the Southwest- Site Number : 8400001
RECRUITINGDallas, Texas, 75231, United States
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Retina Macula Institute of Arizona- Site Number : 8400028
RECRUITINGScottsdale, Arizona, 85255, United States
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Retina Specialist- Site Number : 8400055
RECRUITINGTowson, Maryland, 21204, United States
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Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
RECRUITINGSt. Petersburg, Florida, 33711, United States
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Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033
RECRUITINGBeverly Hills, California, 90211, United States
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Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054
RECRUITINGSacramento, California, 95825, United States
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Retinal Consultants of Texas - San Antonio- Site Number : 8400012
RECRUITINGSan Antonio, Texas, 78240, United States
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Sierra Eye Associates- Site Number : 8400021
RECRUITINGReno, Nevada, 89502, United States
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Southeast Retina Center- Site Number : 8400044
RECRUITINGAugusta, Georgia, 30909, United States
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Texas Retina Associates - Arlington- Site Number : 8400056
RECRUITINGArlington, Texas, 76012, United States
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Texas Retina Associates - Dallas- Site Number : 8400006
RECRUITINGDallas, Texas, 75231, United States
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The Retina Group of Washington - Chevy Chase- Site Number : 8400009
RECRUITINGChevy Chase, Maryland, 20815, United States
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The Retina Partners- Site Number : 8400040
RECRUITINGEncino, California, 91436, United States
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University Retina - Lemont- Site Number : 8400005
RECRUITINGLemont, Illinois, 60439, United States
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Vitreo Retinal Associates - Gainesville- Site Number : 8400004
RECRUITINGGainesville, Florida, 32607, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new eye injection protect vision in geographic atrophy?
- Can genetics predict the worsening of geographic atrophy?
- New eye imaging could reveal hidden clues to vision loss
- A new eye camera may spot stressed cells before vision loss begins
- Gene therapy injection aims to halt blinding eye disease
- Eye imaging showdown: which device measures macular damage best?