SAR402663 for Macular Degeneration

Recruiting at 8 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

Trial Summary

What is the purpose of this trial?

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 neovascular age-related macular degeneration. Participants will be enrolled in one of 2 parts: * In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants * In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants and investigators will be masked to dose. After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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