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

NCT07215234 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: DFI182312025-524508-31
• Study Type: interventional
• Target: 104
• Locations: 2 countries
• Sites: 17

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).

Conditions

Geographic Atrophy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Study Arms (4)

Part I - SAR446597 open-label (OL)

EXPERIMENTAL

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

Part II - SAR446597 Dose A

EXPERIMENTAL

Participants will receive SAR at a dose specified for each arm.

Drug: SAR446597

Part II - SAR446597 Dose B

EXPERIMENTAL

Participants will receive SAR at a dose specified for each arm.

Drug: SAR446597

Part II - Sham control

SHAM COMPARATOR

Participants will receive Sham at a dose specified for each arm.

Drug: Sham Comparator

Interventions

SAR446597 DRUG

Intravitreal injection

Part I - SAR446597 open-label (OL); Part II - SAR446597 Dose A; Part II - SAR446597 Dose B

Sham Comparator DRUG

Sham injection

Part II - Sham control

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (17)

Associated Retina Consultants - Peoria- Site Number : 8400011

Peoria, Arizona, 85381, United States

RECRUITING

Retina Macula Institute of Arizona- Site Number : 8400028

Scottsdale, Arizona, 85255, United States

RECRUITING

Vitreo Retinal Associates - Gainesville- Site Number : 8400004

Gainesville, Florida, 32607, United States

RECRUITING

Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002

St. Petersburg, Florida, 33711, United States

RECRUITING

University Retina - Lemont- Site Number : 8400005

Lemont, Illinois, 60439, United States

RECRUITING

The Retina Group of Washington - Chevy Chase- Site Number : 8400009

Chevy Chase, Maryland, 20815, United States

RECRUITING

Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003

Hagerstown, Maryland, 21740, United States

RECRUITING

Oregon Retina- Site Number : 8400017

Eugene, Oregon, 97401, United States

RECRUITING

Mid Atlantic Retina - Bethlehem- Site Number : 8400031

Bethlehem, Pennsylvania, 18017-9412, United States

RECRUITING

Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007

Austin, Texas, 78750, United States

RECRUITING

Retina Consultants of Texas - Bellaire- Site Number : 8400019

Bellaire, Texas, 77401, United States

RECRUITING

Retina Foundation of the Southwest- Site Number : 8400001

Dallas, Texas, 75231, United States

RECRUITING

Texas Retina Associates - Dallas- Site Number : 8400006

Dallas, Texas, 75231, United States

RECRUITING

Retinal Consultants of Texas - San Antonio- Site Number : 8400012

San Antonio, Texas, 78240, United States

RECRUITING

Investigational Site Number : 0360003

Sydney, New South Wales, 2000, Australia

RECRUITING

Investigational Site Number : 0360002

Adelaide, South Australia, 5000, Australia

RECRUITING

Investigational Site Number : 0360001

East Melbourne, Victoria, 3002, Australia

RECRUITING

Related Links

• DFI18231 Plain Language Results Summary

MeSH Terms

Conditions

Geographic Atrophy

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases

Central Study Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610; contact-us@sanofi.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2025
• First Posted: October 10, 2025
• Study Start: October 9, 2025
• Primary Completion (Estimated): October 13, 2027
• Study Completion (Estimated): July 22, 2032
• Last Updated: April 21, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (14); AU (3)