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Clinical Trials in the USA / NCT06660667
Active, not recruiting Phase 1/2

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

NCT06660667 · tracked via the Priya Life Science USA tracker
Sponsor
Sanofi
Phase
Phase 1/2
Started
2024-11-21
Last updated
2026-07-16

Condition(s) studied

Neovascular Age-related Macular Degeneration

Investigational drug(s) / intervention(s)

SAR402663Diluent

SAR402663: Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection

Diluent: Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection

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, 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
90 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • 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

Trial sites (26)

FacilityCityRegionStatus
Associated Retina Consultants - Phoenix- Site Number : 8400011 Phoenix Arizona
Retina Macula Institute of Arizona- Site Number : 8400028 Scottsdale Arizona
California Retina Consultants - Bakersfield- Site Number : 8400001 Bakersfield California
Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023 Beverly Hills California
Vitreo Retinal Associates - Gainesville- Site Number : 8400004 Gainesville Florida
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 St. Petersburg Florida
Southeast Retina Center- Site Number : 8400010 Augusta Georgia
University Retina - Lemont- Site Number : 8400005 Lemont Illinois
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 Hagerstown Maryland
Retina Specialist- Site Number : 8400020 Towson Maryland
Ophthalmic Consultants of Boston - Boston- Site Number : 8400009 Boston Massachusetts
Sierra Eye Associates- Site Number : 8400021 Reno Nevada
North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400033 Wake Forest North Carolina
Oregon Retina- Site Number : 8400017 Eugene Oregon
Mid Atlantic Retina- Site Number : 8400032 Bethlehem Pennsylvania
Charleston Neuroscience Institute - Ladson- Site Number : 8400016 Ladson South Carolina
Charles Retina Institution- Site Number : 8400018 Germantown Tennessee
Retina Research Institute of Texas- Site Number : 8400008 Abilene Texas
Austin Research Center for Retina- Site Number : 8400015 Austin Texas
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007 Austin Texas
Texas Retina Associates - Dallas- Site Number : 8400006 Dallas Texas
Medical Center Ophthalmology Associates- Site Number : 8400030 San Antonio Texas
Retinal Consultants of Texas - San Antonio- Site Number : 8400012 San Antonio Texas
Retina Consultants of Texas - The Woodlands- Site Number : 8400019 The Woodlands Texas
Investigational Site Number : 8260024 London Westminster
Investigational Site Number : 8260027 Liverpool United Kingdom

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Other trials for the same condition

Long-term Follow-Up Study of RGX-314 and Fellow Eye Substudy Enrolling by invitation
Safety, Tolerability and PK of Subcutaneous D-4517.2 in Subjects With Wet AMD or DME Active, not recruiting
Study to Evaluate the Efficacy and Safety of Intravitreal OTX-TKI (Ocular Therapeutix) (Axitinib Implant) in Subjects With Neovascular Age-Related Macular Degeneration Active, not recruiting
Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA] Active, not recruiting
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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06660667 on ClinicalTrials.gov ↗ ← All trials in the USA