A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Study of a One-Time Eye Injection for Geographic Atrophy From AMD
Study Overview
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).
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Geographic Atrophy
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Age: 60 years or above
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Gender: All
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.
The purpose of this research study is to learn about the effects and safety of a one-time eye injection in people with geographic atrophy caused by age-related macular degeneration (AMD).
Participants will receive a one-time injection into the study eye of an investigational study drug. In one part of the study, some participants may receive a sham procedure instead. A sham procedure is made to look like the real treatment but does not include the active study drug.
Who can participate:
Adults 60 years and older with geographic atrophy from AMD may be able to participate if they:
- Have a diagnosis of geographic atrophy secondary to age-related macular degeneration
- Have visual acuity in the study eye within the range needed for the study
- Have a geographic atrophy lesion size in the study eye within the range needed for the study
Study timeline and visits:
Participation lasts about 5 years (about 2 years in the main part of the study, followed by about 3 years of extended follow-up).
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