A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
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
2 other identifiers
interventional
66
2 countries
26
Brief 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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Nov 2024
Longer than P75 for phase_1
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2024
CompletedFirst Posted
Study publicly available on registry
October 28, 2024
CompletedStudy Start
First participant enrolled
November 21, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2031
July 16, 2026
July 1, 2026
2.5 years
October 25, 2024
July 15, 2026
Conditions
Outcome Measures
Primary Outcomes (6)
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Day 1 to Week 52
Secondary Outcomes (5)
Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy
Day 1 to Week 52 and Week 8 to Week 52
Annualized injection rates of anti-VEGF therapy
Day 1 to Week 52
Change from baseline in BCVA using the ETDRS letter score
Baseline, Week 52
Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline
Baseline, Week 52
Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT)
Baseline, Week 52
Study Arms (3)
Part I - SAR402663 open-label (OL)
EXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants.
Part II - SAR402663 Dose A
EXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1.
Part II - SAR402663 Dose B
EXPERIMENTALParticipants will receive a single dose of SAR402663 on Day 1.
Interventions
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (26)
Associated Retina Consultants - Phoenix- Site Number : 8400011
Phoenix, Arizona, 85020, United States
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, 85255, United States
California Retina Consultants - Bakersfield- Site Number : 8400001
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023
Beverly Hills, California, 90211, United States
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, 32607, United States
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida, 33711, United States
Southeast Retina Center- Site Number : 8400010
Augusta, Georgia, 30909, United States
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, 60439, United States
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland, 21740, United States
Retina Specialist- Site Number : 8400020
Towson, Maryland, 21204, United States
Ophthalmic Consultants of Boston - Boston- Site Number : 8400009
Boston, Massachusetts, 02114, United States
Sierra Eye Associates- Site Number : 8400021
Reno, Nevada, 89502, United States
North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400033
Wake Forest, North Carolina, 27587-3803, United States
Oregon Retina- Site Number : 8400017
Eugene, Oregon, 97401, United States
Mid Atlantic Retina- Site Number : 8400032
Bethlehem, Pennsylvania, 18017-9412, United States
Charleston Neuroscience Institute - Ladson- Site Number : 8400016
Ladson, South Carolina, 29456, United States
Charles Retina Institution- Site Number : 8400018
Germantown, Tennessee, 38138, United States
Retina Research Institute of Texas- Site Number : 8400008
Abilene, Texas, 79606, United States
Austin Research Center for Retina- Site Number : 8400015
Austin, Texas, 78705, United States
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas, 78750, United States
Texas Retina Associates - Dallas- Site Number : 8400006
Dallas, Texas, 75231, United States
Medical Center Ophthalmology Associates- Site Number : 8400030
San Antonio, Texas, 78240, United States
Retinal Consultants of Texas - San Antonio- Site Number : 8400012
San Antonio, Texas, 78240, United States
Retina Consultants of Texas - The Woodlands- Site Number : 8400019
The Woodlands, Texas, 77384, United States
Investigational Site Number : 8260024
London, Westminster, W1G 7LB, United Kingdom
Investigational Site Number : 8260027
Liverpool, L7 8XP, United Kingdom
Related Links
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Part I is an open-label study. Part II is partially masked in which participants, Investigators, and outcomes assessors including reading center (RC) are masked to study intervention. The Sponsor is not masked. Masking will be maintained until all participants reach 52 weeks of follow up after SAR402663 dose.
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2024
First Posted
October 28, 2024
Study Start
November 21, 2024
Primary Completion (Estimated)
May 18, 2027
Study Completion (Estimated)
June 30, 2031
Last Updated
July 16, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
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