A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration

November 19, 2025 updated by: Sanofi

A Phase 1/2 Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR402663 in Participants With Neovascular Age-related Macular Degeneration

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, investigators and outcomes assessors 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

66

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Trial Transparency email recommended (Toll free for US & Canada)
  • Phone Number: option 6 800-633-1610
  • Email: Contact-US@sanofi.com

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85020
        • Recruiting
        • Site # 8400011
      • Scottsdale, Arizona, United States, 85281
        • Recruiting
        • Site # 8400028
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Site # 8400023
    • Florida
      • Gainesville, Florida, United States, 32607
        • Recruiting
        • Site # 8400004
      • St. Petersburg, Florida, United States, 33711
        • Recruiting
        • Site # 8400002
    • Georgia
      • Augusta, Georgia, United States, 30909
        • Recruiting
        • Site # 8400010
    • Illinois
      • Lemont, Illinois, United States, 60439
        • Recruiting
        • Site # 8400005
    • Maryland
      • Hagerstown, Maryland, United States, 21740
        • Recruiting
        • Site # 8400003
    • Massachusetts
      • Boston, Massachusetts, United States, 02114-2517
        • Recruiting
        • Site # 8400009
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Site # 8400021
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Recruiting
        • Site # 8400017
    • South Carolina
      • Ladson, South Carolina, United States, 29414
        • Recruiting
        • Site # 8400016
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Recruiting
        • Site # 8400018
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Site # 8400008
      • Austin, Texas, United States, 78705
        • Recruiting
        • Site # 8400015
      • Austin, Texas, United States, 78750
        • Recruiting
        • Site # 8400007
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Site # 8400006
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • Site # 8400030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Between 50 and 90 years of age
  • Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
  • Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200
  • Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
  • Demonstrated a response to anti-VEGF treatment

Exclusion Criteria:

  • Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
  • History of active ocular infection in the study eye in 6 months prior to screening
  • Active uncontrolled glaucoma in the study eye
  • History of uveitis in either eye
  • Current use of ocular corticosteroids in the study eye
  • Previous gene therapy
  • 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 potential participation in a clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Part I - SAR402663 open-label (OL)
Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.
Biological: SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Drug: Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Experimental: Part II - SAR402663 Dose A
Participants will receive a single dose of SAR402663 on Day 1.
Biological: SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Drug: Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Experimental: Part II - SAR402663 Dose B
Participants will receive a single dose of SAR402663 on Day 1.
Biological: SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Drug: Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Time Frame: Day 1 to Week 52
Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Time Frame: Day 1 to Week 52
Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Time Frame: Day 1 to Week 52
Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Time Frame: Day 1 to Week 52
Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Time Frame: Day 1 to Week 52
Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Time Frame: Day 1 to Week 52
Day 1 to Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Annualized injection rates of anti-VEGF therapy
Time Frame: Day 1 to Week 52
Day 1 to Week 52
Change from baseline in BCVA using the ETDRS letter score
Time Frame: Baseline, Week 52
Visual function of the study eye was assessed at a distance of 4 meters using the best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score. BCVA scale range is 0 (worst score) to 100 (best score).
Baseline, Week 52
Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline
Time Frame: Baseline, Week 52
Baseline, Week 52
Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT)
Time Frame: Baseline, Week 52
Baseline, Week 52
Percentage of participants not requiring supplemental anti-vascular endothelial growth factor (VEGF) therapy
Time Frame: Day 1 to Week 52 and Week 8 to Week 52
Day 1 to Week 52 and Week 8 to Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanofi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 21, 2024

Primary Completion (Estimated)

May 18, 2027

Study Completion (Estimated)

June 30, 2031

Study Registration Dates

First Submitted

October 25, 2024

First Submitted That Met QC Criteria

October 25, 2024

First Posted (Actual)

October 28, 2024

Study Record Updates

Last Update Posted (Actual)

November 21, 2025

Last Update Submitted That Met QC Criteria

November 19, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DFI17940
  • U1111-1299-1827 (Registry Identifier: ICTRP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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