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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Sanofi
Study ID
NCT06660667
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex
ALL
Age
50 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • SAR402663 — BIOLOGICAL
    Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
  • Diluent — DRUG
    Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection

Study Details

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.

Key Dates

Start date
Nov 21, 2024
Status verified
Nov 2025
Primary completion
May 18, 2027
Completion
Jun 30, 2031

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • Experimental: Part II - SAR402663 Dose A
    Participants will receive a single dose of SAR402663 on Day 1.
  • Experimental: Part II - SAR402663 Dose B
    Participants will receive a single dose of SAR402663 on Day 1.

Primary Outcome Measure

Incidence and severity of ocular treatment emergent adverse event (TEAEs) [ Time Frame: Day 1 to Week 52 ]

Central Contacts

  • Trial Transparency email recommended (Toll free for US & Canada)
    800-633-1610
    [email protected]

Locations (18)

FacilityCityStateZIPSite coordinators
Site # 8400011PhoenixArizona85020-
Site # 8400028ScottsdaleArizona85281-
Site # 8400023Beverly HillsCalifornia90211-
Site # 8400004GainesvilleFlorida32607-
Site # 8400002St. PetersburgFlorida33711-
Site # 8400010AugustaGeorgia30909-
Site # 8400005LemontIllinois60439-
Site # 8400003HagerstownMaryland21740-
Site # 8400009BostonMassachusetts02114-2517-
Site # 8400021RenoNevada89502-
Site # 8400017EugeneOregon97401-
Site # 8400016LadsonSouth Carolina29414-
Site # 8400018GermantownTennessee38138-
Site # 8400008AbileneTexas79606-
Site # 8400007AustinTexas78750-
Site # 8400015AustinTexas78705-
Site # 8400006DallasTexas75231-
Site # 8400030San AntonioTexas78240-

Find similar trials in Phoenix, AZ

By research site
Site # 8400011· Phoenix, AZSite # 8400028· Scottsdale, AZSite # 8400023· Beverly Hills, CASite # 8400004· Gainesville, FLSite # 8400002· St. Petersburg, FLSite # 8400010· Augusta, GA

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