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Recruiting 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

Phase I / Phase II Interventional Geographic Atrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: SAR446597, Sham Comparator.
Who it may be relevant to
Registry conditions: Geographic Atrophy. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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).

Interventions

  • Drug SAR446597
    Intravitreal injection
  • Drug Sham Comparator
    Sham injection

Primary outcome measures

  • Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) [Time frame: Day 1 to Week 104]
  • Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs) [Time frame: Day 1 to Week 104]
Secondary outcome measures (4)
  • Change in square root-transformed (mm) and untransformed area (mm2) of GA [Time frame: Baseline, Week 52, Week 104]
  • 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]
  • Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye [Time frame: Baseline, Week 52, Week 104]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Double blind
Primary purpose
Treatment

Study locations

United States · 15 centers
  • Associated Retina Consultants - Peoria- Site Number : 8400011 — Peoria
  • Retina Macula Institute of Arizona- Site Number : 8400028 — Scottsdale
  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004 — Gainesville
  • Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002 — St. Petersburg
  • University Retina - Lemont- Site Number : 8400005 — Lemont
  • The Retina Group of Washington - Chevy Chase- Site Number : 8400009 — Chevy Chase
  • Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003 — Hagerstown
  • Oregon Retina- Site Number : 8400017 — Eugene
  • … and 7 more centers
Australia · 3 centers
  • Investigational Site Number : 0360003 — Sydney
  • Investigational Site Number : 0360002 — Adelaide
  • Investigational Site Number : 0360001 — East Melbourne

Identifiers

NCT: NCT07215234 · DFI18231 · 2025-524508-31

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗