A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration
Not Applicable
Recruiting
- Conditions
- Geographic Atrophy
- Interventions
- Drug: SAR446597Drug: Sham Comparator
- Registration Number
- NCT07215234
- Lead Sponsor
- Sanofi
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 104
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part I - SAR446597 open-label (OL) SAR446597 Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants. Part II - SAR446597 Dose A SAR446597 Participants will receive SAR at a dose specified for each arm. Part II - SAR446597 Dose B SAR446597 Participants will receive SAR at a dose specified for each arm. Part II - Sham control Sham Comparator Participants will receive Sham at a dose specified for each arm.
- Primary Outcome Measures
Name Time Method Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) Day 1 to Week 104 Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs) Day 1 to Week 104
- Secondary Outcome Measures
Name Time Method Change in square root-transformed (mm) and untransformed area (mm2) of GA Baseline, Week 52, Week 104 Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart Baseline, Week 52, Week 104 Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye Baseline, Week 52, Week 104 Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters Week 260 or End of Study
Trial Locations
- Locations (2)
Associated Retina Consultants - Peoria - DocTrials - PPDS- Site Number : 8400011
🇺🇸Peoria, Arizona, United States
Vitreo Retinal Associates, P.A.- Site Number : 8400004
🇺🇸Gainesville, Florida, United States
Associated Retina Consultants - Peoria - DocTrials - PPDS- Site Number : 8400011🇺🇸Peoria, Arizona, United States