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 Eye Injection for Geographic Atrophy in Age-related Macular Degeneration
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
This study investigates the safety and effectiveness of a one-time injection into the eye for participants with Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD). Participants will receive a one-time injection directly into the eye. Some participants in the second part of the study may receive a sham injection, which is a procedure that mimics the actual injection but does not deliver the investigational medication. The study will monitor participants for safety and any changes in their vision.
- Who can participate: Participants aged 60 years or older with a diagnosis of GA secondary to AMD may join. Key eligibility includes specific vision and lesion size criteria in the study eye. Participants must not have other eye conditions that could interfere with the study.
- Study details: Participants will receive a one-time injection into the eye. Some may receive a sham injection, which looks like the investigational injection but contains no medicine. The study will track safety and changes in vision.
- Study timelines: The study will last approximately 5 years.
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