SAR402663 for Macular Degeneration

Recruiting at 17 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Sanofi

Must be taking: Anti-VEGF

Must not be taking: Corticosteroids

Disqualifiers: Glaucoma, Uveitis, Infections, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called SAR402663 for individuals with neovascular age-related macular degeneration (nAMD). It tests the safety and effectiveness of a one-time injection into one eye at various dose levels. The trial consists of two parts: the first determines the appropriate dose, and the second assesses the effectiveness of those doses. Individuals with nAMD who have previously used anti-VEGF treatments may be suitable candidates. Participants will undergo regular monitoring for a year and follow-up for up to five years to evaluate the duration of the treatment effects. As a Phase 1, Phase 2 trial, this research aims to understand the treatment's function in people and measure its effectiveness in an initial, smaller group, offering participants an opportunity to contribute to groundbreaking advancements in eye care.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you must not have used ocular or systemic corticosteroids in the 3 months before screening.

Is there any evidence suggesting that SAR402663 is likely to be safe for humans?

Research has shown that SAR402663 is being tested for safety in treating macular degeneration. As this treatment remains in the early stages of research, detailed safety information is not yet fully available. However, the FDA has granted it Fast Track Designation, indicating promise and potential benefits that justify faster development and review.

In these trials, researchers administer SAR402663 as a one-time injection into the eye to directly target the affected area. While specific side effects are still under study, the trial aims to test different doses to identify any side effects and determine the most tolerable dose.

If SAR402663 proves safe and effective, it could offer a new way to manage this eye condition. Researchers will closely monitor participants to quickly address any side effects. Joining such a trial contributes to research that could benefit many others in the future. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for macular degeneration?

Researchers are excited about SAR402663 for macular degeneration because it offers a potentially novel approach compared to the current standard treatments like anti-VEGF injections (e.g., ranibizumab or aflibercept). Most existing therapies work by targeting vascular endothelial growth factor to reduce abnormal blood vessel growth and leakage in the eye. However, SAR402663 might have a different mechanism of action, which could provide benefits to patients who do not respond well to current options. Additionally, its ability to be administered in a single dose could simplify treatment regimens and improve patient compliance.

What evidence suggests that SAR402663 might be an effective treatment for macular degeneration?

Research has shown that SAR402663 is an experimental treatment designed to help people with neovascular age-related macular degeneration (nAMD), a major cause of vision loss. SAR402663 delivers a gene that produces a protein to block VEGF, a substance that causes abnormal blood vessel growth in the eye. This method aims to slow or stop the disease's progression. Early results suggest that this one-time gene therapy might have long-lasting effects, reducing the need for frequent eye injections. Although more research is needed, the treatment has shown enough promise to receive fast track designation in the US, highlighting its potential importance in treating nAMD. Participants in this trial will receive different doses of SAR402663 to evaluate its effectiveness and safety. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults aged 50-90 with neovascular age-related macular degeneration (nAMD) who've responded to prior aflibercept treatment. They must have certain levels of vision in the study eye and be currently receiving anti-VEGF therapy.

Inclusion Criteria

I am between 50 and 90 years old.

I have been diagnosed with a specific eye condition due to aging.

I responded well to aflibercept treatment before.

Exclusion Criteria

I have had uveitis in one or both eyes.

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

I have uncontrolled glaucoma in one eye.

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 single-eye intravitreal dose of SAR402663

1 day

1 visit (in-person)

Regular Assessments

Participants undergo regular assessments to evaluate safety and efficacy over 12 months

12 months

Extended Follow-up

Participants enter an extended follow-up phase for assessment of safety and durability of clinical activity through Year 5

4 years

What Are the Treatments Tested in This Trial?

Interventions

• SAR402663

Trial Overview The trial tests a one-time intravitreal dose of SAR402663. Part I explores multiple doses, while Part II randomizes participants to two selected doses, keeping both participants and investigators unaware of which dose is given.

How Is the Trial Designed?

Group I: Part II - SAR402663 Dose B Experimental Treatment 2 Interventions

Participants will receive a single dose of SAR402663 on Day 1.

Group II: Part II - SAR402663 Dose A Experimental Treatment 2 Interventions

Participants will receive a single dose of SAR402663 on Day 1.

Group III: Part I - SAR402663 open-label (OL) Experimental Treatment 2 Interventions

Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.

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. clinicaltrials.gov clinicaltrials.gov/study/NCT06660667

A Safety and Efficacy Study of One-time SAR402663 in ... This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with ...

2. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/en/listing/312991/a-safety-and-efficacy/

A Safety and Efficacy Study of One-time SAR402663 This study investigates the safety and effects of an investigational medication given as a one-time injection into one eye for people with neovascular ...

3. cgtlive.com cgtlive.com/view/sanofi-neovascular-age-related-macular-degeneration-gene-therapy-sar402663-fda-fast-track-designation

Sanofi's Neovascular Age-Related Macular Degeneration ... SAR402663 comprises a onetime intravitreal treatment and is intended to inhibit VEGF by providing a gene for soluble FLT01.

4. sanofi.com sanofi.com/en/media-room/press-releases/2025/2025-09-11-05-00-00-3148313

Press Release: Sanofi's SAR402663 earns fast track ... Press Release: Sanofi's SAR402663 earns fast track designation in the US for neovascular age-related macular degeneration. September 11, 2025.

5. ophthalmologytimes.com ophthalmologytimes.com/view/sar402663-earns-fast-track-designation-for-treatment-of-namd

SAR402663 earns fast track designation for treatment of ... SAR402663 is an investigational one-time intravitreal gene therapy for the treatment of neovascular age-related macular degeneration (nAMD).

6. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/551915

A Safety and Efficacy Study of One-time SAR402663 in ... This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with ...

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- ...

8. empr.com empr.com/news/gene-therapy-fast-tracked-for-neovascular-amd/

Gene Therapy Fast Tracked for Neovascular AMD - MPR SAR402663 is an investigational one-time intravitreal gene therapy that delivers genetic material encoding soluble FLT01. Through the inhibition ...