A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Conditions

• Geographic Atrophy

Eligibility Criteria

Sex

ALL

Age

60 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• SAR446597 — DRUG
  Intravitreal injection
• Sham Comparator — DRUG
  Sham injection

Study Details

This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD). The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase. The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).

Key Dates

First listed

Oct 10, 2025

Start date

Oct 9, 2025

Status verified

Sep 2026

Primary completion

Oct 13, 2027

Completion

Jul 22, 2032

Study Design

Enrollment

104 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Part I - SAR446597 open-label (OL)
  Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
• Experimental: Part II - SAR446597 Dose A
  Participants will receive SAR at a dose specified for each arm.
• Experimental: Part II - SAR446597 Dose B
  Participants will receive SAR at a dose specified for each arm.
• Sham Comparator: Part II - Sham control
  Participants will receive Sham at a dose specified for each arm.

Primary Outcome Measure

Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) [ Time Frame: Day 1 to Week 104 ]

Central Contacts

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

Locations (28)

Find similar trials in Peoria, AZ

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