SAR446597 for Age-Related Macular Degeneration
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.12345Why 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.12367
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a one-time intravitreal injection of SAR446597 or sham
Core Phase
Participants are monitored for safety, tolerability, and efficacy over a 2-year period
Extended Follow-Up
Participants are monitored for long-term safety and efficacy over an additional 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?
4
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive SAR at a dose specified for each arm.
Participants will receive SAR at a dose specified for each arm.
Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
Participants will receive Sham at a dose specified for each arm.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sanofi
Lead Sponsor
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
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.
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 ...
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-degenerationA 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 ...
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-degenerationFDA 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- ...
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