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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). 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).

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SAR446597

Intravitreal injection

DRUG

Sham Comparator

Sham injection

Locations (13)

Associated Retina Consultants - Peoria- 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
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida, United States
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, United States
The Retina Group of Washington - Chevy Chase- Site Number : 8400009
Chevy Chase, Maryland, United States
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland, United States
Oregon Retina- Site Number : 8400017
Eugene, Oregon, United States
Mid Atlantic Retina- Site Number : 8400031
Bethlehem, Pennsylvania, United States
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas, United States
Retina Foundation of the Southwest- Site Number : 8400001
Dallas, Texas, United States
Texas Retina Associates - Dallas- Site Number : 8400006
Dallas, Texas, United States
Retinal Consultants of Texas - San Antonio- Site Number : 8400012
San Antonio, Texas, United States