A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
NCT ID: NCT07215234
Last Updated: 2025-11-06
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
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RECRUITING
PHASE1/PHASE2
104 participants
INTERVENTIONAL
2025-10-09
2032-07-22
Brief Summary
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The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.
The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
DOUBLE
Study Groups
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Part I - SAR446597 open-label (OL)
Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
SAR446597
Intravitreal injection
Part II - SAR446597 Dose A
Participants will receive SAR at a dose specified for each arm.
SAR446597
Intravitreal injection
Part II - SAR446597 Dose B
Participants will receive SAR at a dose specified for each arm.
SAR446597
Intravitreal injection
Part II - Sham control
Participants will receive Sham at a dose specified for each arm.
Sham Comparator
Sham periocular injection
Interventions
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SAR446597
Intravitreal injection
Sham Comparator
Sham periocular injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
60 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Associated Retina Consultants - Peoria - DocTrials - PPDS- Site Number : 8400011
Peoria, Arizona, United States
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, United States
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, United States
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, United States
Oregon Retina- Site Number : 8400017
Eugene, Oregon, United States
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Phone: 800-633-1610
Email: [email protected]
Related Links
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DFI18231 Plain Language Results Summary
Other Identifiers
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DFI18231
Identifier Type: -
Identifier Source: org_study_id