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

Purpose

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).

Condition

  • Geographic Atrophy

Eligibility

Eligible Ages
Over 60 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
  • Drug: SAR446597
    Intravitreal injection
Experimental
Part II - SAR446597 Dose A 		Participants will receive SAR at a dose specified for each arm.
  • Drug: SAR446597
    Intravitreal injection
Experimental
Part II - SAR446597 Dose B 		Participants will receive SAR at a dose specified for each arm.
  • Drug: SAR446597
    Intravitreal injection
Sham Comparator
Part II - Sham control 		Participants will receive Sham at a dose specified for each arm.
  • Drug: Sham Comparator
    Sham periocular injection

Recruiting Locations

Associated Retina Consultants - Peoria - DocTrials - PPDS- Site Number : 8400011
Peoria 5308480, Arizona 5551752 85381

Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale 5313457, Arizona 5551752 85255

Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville 4156404, Florida 4155751 32607

University Retina - Lemont- Site Number : 8400005
Lemont 4899581, Illinois 4896861 60439

Oregon Retina- Site Number : 8400017
Eugene 5725846, Oregon 5744337 97401

Retina Foundation of the Southwest- Site Number : 8400001
Dallas 4684888, Texas 4736286 75231

Texas Retina Associates - Dallas- Site Number : 8400006
Dallas 4684888, Texas 4736286 75231

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
contact-us@sanofi.com