A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
NCT ID: NCT06660667
Last Updated: 2025-11-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
66 participants
INTERVENTIONAL
2024-11-21
2031-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
QUADRUPLE
Study Groups
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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.
SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Part II - SAR402663 Dose A
Participants will receive a single dose of SAR402663 on Day 1.
SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Part II - SAR402663 Dose B
Participants will receive a single dose of SAR402663 on Day 1.
SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Interventions
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SAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Diluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
50 Years
90 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Locations
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Site # 8400011
Phoenix, Arizona, United States
Site # 8400028
Scottsdale, Arizona, United States
Site # 8400023
Beverly Hills, California, United States
Site # 8400004
Gainesville, Florida, United States
Site # 8400002
St. Petersburg, Florida, United States
Site # 8400010
Augusta, Georgia, United States
Site # 8400005
Lemont, Illinois, United States
Site # 8400003
Hagerstown, Maryland, United States
Site # 8400009
Boston, Massachusetts, United States
Site # 8400021
Reno, Nevada, United States
Site # 8400017
Eugene, Oregon, United States
Site # 8400016
Ladson, South Carolina, United States
Site # 8400018
Germantown, Tennessee, United States
Site # 8400008
Abilene, Texas, United States
Site # 8400015
Austin, Texas, United States
Site # 8400007
Austin, Texas, United States
Site # 8400006
Dallas, Texas, United States
Site # 8400030
San Antonio, Texas, United States
Countries
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Central Contacts
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Trial Transparency email recommended (Toll free for US & Canada)
Role: CONTACT
Related Links
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DFI17940 Plain Language Results Summary
Other Identifiers
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U1111-1299-1827
Identifier Type: REGISTRY
Identifier Source: secondary_id
DFI17940
Identifier Type: -
Identifier Source: org_study_id
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