Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07215234

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

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).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Geographic Atrophy Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site Number : 0360003, Sydney, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 60 years old or above
  • Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)
  • Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200
  • Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II

Exclusion criteria

  • GA in the study eye caused by a disease different than AMD
  • Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye
  • Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
  • Current or history of systemic complement targeting treatment in the past 12 months
  • Use of ocular corticosteroids for 4 months (for ocular or periocular injections), 6 months (for intraocular implants) or 3 years (for long lasting intraocular implants) prior to screening in the study eye
  • History of macular laser photocoagulation treatment, photodynamic- or thermotherapy or photo biomodulation in the study eye
  • History of active ocular infection in the study eye in 6 months prior to screening
  • Presence of active ocular or periocular infections
  • Active uncontrolled glaucoma in the study eye
  • History of uveitis or scleritis in either eye
  • Previous gene therapy in either eye
  • 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 patient's potential participation in a clinical trial.

Treatment and study plan

SAR446597

Drug

Intravitreal injection

Sham Comparator

Drug

Sham injection

Primary outcomes

  1. Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)

    Time frame: Day 1 to Week 104

  2. Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)

    Time frame: Day 1 to Week 104

Secondary outcomes

  1. Change in square root-transformed (mm) and untransformed area (mm2) of GA

    Time frame: Baseline, Week 52, Week 104

  2. Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart

    Time frame: Baseline, Week 52, Week 104

  3. Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye

    Time frame: Baseline, Week 52, Week 104

  4. Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters

    Time frame: Week 260 or End of Study

Study contacts

Contact information is provided by the study sponsor or research team.

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 1/2, Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Important dates

Study start
2025
Primary completion
2027
Study completion
2032
First posted
Oct 10, 2025
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.