SAR446597 for Age-Related Macular Degeneration

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must not be taking: Anti-VEGF, Corticosteroids

Disqualifiers: Neovascularization, Uncontrolled glaucoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: One-time

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and effectiveness of a one-time injection called SAR446597 for individuals with Geographic Atrophy (GA), a condition linked to Age-related Macular Degeneration (AMD). The trial will examine different doses of SAR446597, comparing them to a control (sham) to assess their effectiveness. Individuals diagnosed with GA due to AMD, who experience vision challenges and have a specific size of GA lesions in their eyes, might be suitable candidates for this study. As a Phase 1, Phase 2 trial, this research focuses on understanding how the treatment works in participants and measuring its effectiveness in an initial, smaller group.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are on treatments that target the complement system or have used certain ocular corticosteroids recently, you may not be eligible to participate.

Is there any evidence suggesting that SAR446597 is likely to be safe for humans?

Research has shown that SAR446597 is being tested for its safety and effectiveness in treating geographic atrophy, a condition related to age-related macular degeneration. While past studies have not provided specific information on side effects, the trial's phase offers some insights.

As a phase 1/2 trial, the safety of the treatment remains under close observation. Early trials often focus on determining whether a treatment is safe for humans, with careful monitoring of any potential side effects or risks.

The FDA has given SAR446597 a fast track designation, indicating the treatment's promise and interest in its potential benefits, though this does not guarantee safety.

Participants in this study will receive a one-time injection directly into the eye, a common procedure for eye conditions. While this method carries its own risks, the primary goal is to assess how well SAR446597 is tolerated.

Overall, specific safety data is not yet available, but the trial will provide more information as it progresses. Participants will be closely monitored for any side effects during the study. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for age-related macular degeneration, which often involve injections into the eye with drugs like anti-VEGF therapies, SAR446597 offers a new approach. Researchers are excited about SAR446597 because it uses a novel mechanism of action targeting specific pathways in the disease process that are not addressed by current options. This could potentially lead to improved outcomes and fewer side effects for patients. Additionally, the trial includes different dosing strategies, which might optimize effectiveness and minimize risks, offering hope for a more tailored treatment approach.

What evidence suggests that SAR446597 might be an effective treatment for age-related macular degeneration?

Research has shown that SAR446597 is under investigation for its potential to treat geographic atrophy (GA), a condition related to age-related macular degeneration (AMD). In this trial, participants will receive either SAR446597 at varying doses or a sham control. The treatment involves a single injection into the eye, aiming to slow the disease's progression. The FDA has granted SAR446597 a fast track designation, indicating that early evidence suggests it could be effective for this condition. While detailed results in humans are still being gathered, the fast track status offers hope for its benefits. The treatment aims to reduce the need for frequent treatments and improve vision for people with GA. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD). Participants will be involved in the study for about 2 years, followed by a 3-year extended follow-up. Specific eligibility criteria are not provided.

Inclusion Criteria

I am 60 years old or older.

I have been diagnosed with GA due to AMD.

My vision in the study eye ranges from slightly impaired to severely impaired.

Exclusion Criteria

History of uveitis or scleritis in either eye

Any significant poorly controlled illness that would preclude study compliance and follow up

I haven't had an eye infection in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a one-time intravitreal injection of SAR446597 or sham

One-time

Core Phase

Participants are monitored for safety, tolerability, and efficacy over a 2-year period

2 years

Extended Follow-Up

Participants are monitored for long-term safety and efficacy over an additional 3 years

3 years

What Are the Treatments Tested in This Trial?

Interventions

• SAR446597

Trial Overview The study tests the safety and effectiveness of a one-time eye injection called SAR446597 compared to a sham treatment. It's designed in two parts and aims to see if this new treatment can help with GA in AMD patients.

How Is the Trial Designed?

Group I: Part II - SAR446597 Dose B Experimental Treatment 1 Intervention

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

Group II: Part II - SAR446597 Dose A Experimental Treatment 1 Intervention

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

Group III: Part I - SAR446597 open-label (OL) Experimental Treatment 1 Intervention

Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.

Group IV: Part II - Sham control Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Citations

1. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-07-16-05-00-00-3116124

Press Release: Sanofi's SAR446597 earns fast track ... Sanofi's SAR446597 earns fast track designation in the US for geographic atrophy due to age-related macular degeneration.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07215234

NCT07215234 | A Safety and Efficacy Study of a One-time ... 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 ...

3. modernretina.com modernretina.com/view/fda-grants-fast-track-designation-to-sar446597

FDA grants fast track designation to SAR446597 Sanofi's SAR446597 receives FDA fast track designation, offering a promising one-time gene therapy for geographic atrophy and reducing treatment frequency.

4. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/SNYNF/pressreleases/35389424/sanofis-new-study-on-sar446597-a-potential-game-changer-for-age-related-macular-degeneration/

Sanofi's New Study on SAR446597: A Potential Game- ... ' This study aims to assess the safety, tolerability, and efficacy of a single intravitreal dose of SAR446597 in treating geographic atrophy due ...

5. trial.medpath.com trial.medpath.com/clinical-trial/7a0dd812f36a7589/nct07215234-sar446597-geographic-atrophy-age-related-macular-degeneration

A Safety and Efficacy Study of a One-time Intravitreal Injection ... 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 ...

6. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/313147/a-safety-and-efficacy-2/

Study on Eye Injection for Vision Loss in Older Adults A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related ...

7. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/fda-fast-tracks-sanofi-intravitreal-gene-therapy-neovascular-age-related-macular-degeneration

FDA Fast Tracks Sanofi's Intravitreal Gene Therapy for ... The FDA has granted Fast Track Designation to Sanofi's SAR402663, an investigational one-time intravitreal gene therapy for neovascular age- ...