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RecruitingPhase 1/Phase 2

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

Sanofi · NCT07215234

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 60+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 1, Phase 2
Target enrollment
104
US sites recruiting
31
Study start
October 9, 2025
Record last updated
October 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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).

Being studied: SAR446597; Sham Comparator

Conditions: Geographic Atrophy

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • Associated Retina Consultants - Peoria- Site Number : 8400011

    Peoria, AZ 85381

  • Retina Macula Institute of Arizona- Site Number : 8400028

    Scottsdale, AZ 85255

  • Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400033

    Beverly Hills, CA 90211

  • The Retina Partners- Site Number : 8400040

    Encino, CA 91436

  • California Retina Consultants - Oxnard - North Ventura Road- Site Number : 8400014

    Oxnard, CA 93036

  • Retinal Consultants - Sacramento - Parkcenter Drive- Site Number : 8400054

    Sacramento, CA 95825

  • Macula Retina Vitreous Center - Torrance- Site Number : 8400053

    Torrance, CA 90503

  • Bay Area Retina Associates - Walnut Creek - Lennon Lane- Site Number : 8400039

    Walnut Creek, CA 94598

  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004

    Gainesville, FL 32607

  • Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002

    St. Petersburg, FL 33711

  • East Florida Eye Institute- Site Number : 8400038

    Stuart, FL 34994

  • Southeast Retina Center- Site Number : 8400044

    Augusta, GA 30909

  • University Retina - Lemont- Site Number : 8400005

    Lemont, IL 60439

  • The Retina Group of Washington - Chevy Chase- Site Number : 8400009

    Chevy Chase, MD 20815

  • Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003

    Hagerstown, MD 21740

  • Retina Specialist- Site Number : 8400055

    Towson, MD 21204

  • Sierra Eye Associates- Site Number : 8400021

    Reno, NV 89502

  • North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400059

    Wake Forest, NC 27587-3803

  • Oregon Retina- Site Number : 8400017

    Eugene, OR 97401

  • Mid Atlantic Retina - Bethlehem- Site Number : 8400031

    Bethlehem, PA 18017-9412

  • Erie Retina Research- Site Number : 8400035

    Erie, PA 16505

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400016

    Ladson, SC 29456

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400046

    Ladson, SC 29456

  • Texas Retina Associates - Arlington- Site Number : 8400056

    Arlington, TX 76012

  • Retina Consultants of Austin- Site Number : 8400015

    Austin, TX 78705

  • Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007

    Austin, TX 78750

  • Retina Consultants of Texas - Bellaire- Site Number : 8400019

    Bellaire, TX 77401

  • Retina Foundation of the Southwest- Site Number : 8400001

    Dallas, TX 75231

  • Texas Retina Associates - Dallas- Site Number : 8400006

    Dallas, TX 75231

  • Retinal Consultants of Texas - San Antonio- Site Number : 8400012

    San Antonio, TX 78240

  • Retina Center of Texas (RCT) - Southlake- Site Number : 8400048

    Southlake, TX 76092

Study contacts (from the official record)

  • Trial Transparency email recommended (Toll free for US & Canada) · 800-633-1610 · contact-us@sanofi.com
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A Safety and Efficacy Study of a One-time Intravitreal Injection… (NCT07215234) | Bored Studies