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

Last updated: April 2, 2025
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

1/2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Diluent

SAR402663

Clinical Study ID

NCT06660667
DFI17940
U1111-1299-1827
  • Ages 50-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Between 50 and 90 years of age

  • Participants with diagnosis of macular neovascularization secondary to age-relatedmacular degeneration (nAMD)

  • Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for doseescalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200

  • Currently receiving anti-VEGF treatment in the study eye

  • Demonstrated a response to aflibercept in the pre-treatment period

Exclusion

Exclusion Criteria:

  • Any condition in the study eye that may prevent visual acuity improvement orinterfere 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

  • Use of ocular corticosteroids in the 3 months prior to screening

  • Previous gene therapy

  • Any significant poorly controlled illness that would preclude study compliance andfollow up

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Study Design

Total Participants: 66
Treatment Group(s): 2
Primary Treatment: Diluent
Phase: 1/2
Study Start date:
November 21, 2024
Estimated Completion Date:
June 30, 2031

Connect with a study center

  • Site # 8400011

    Phoenix, Arizona 85020
    United States

    Active - Recruiting

  • Site # 8400023

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Site # 8400004

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Site # 8400005

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • Site # 8400021

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Site # 8400017

    Eugene, Oregon 97401
    United States

    Active - Recruiting

  • Site # 8400018

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Site # 8400015

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Site # 8400006

    Dallas, Texas 75231
    United States

    Active - Recruiting

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