AzTrials
AzTrials

Geographic AtrophyPhase 1/2NCT07215234

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

A Phase 1/2 study testing SAR446597 in people with Geographic Atrophy, run by Sanofi at 35 sites in 3 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial summary

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). Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Geographic Atrophy
What is being tested?
SAR446597
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
104 participants
Where
35 sitesin 3 countries
Study dates
9 Oct 2025to 22 Jul 2032
Phase
Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 13Show fewer
  • 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.

Trial locations and contacts

35 sites in 3 countries. Contact the study team or a site near you to ask about taking part.

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

800-633-1610 ext. option 6

contact-us@sanofi.com

35 sites in 3 countries

United States31 sites, 31 recruiting

  • Texas Retina Associates - Arlington- Site Number : 8400056

    Arlington, Texas, 76012

    Recruiting

  • Southeast Retina Center- Site Number : 8400044

    Augusta, Georgia, 30909

    Recruiting

  • Retina Consultants of Austin- Site Number : 8400015

    Austin, Texas, 78705

    Recruiting

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

    Austin, Texas, 78750

    Recruiting

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

    Bellaire, Texas, 77401

    Recruiting

  • Mid Atlantic Retina - Bethlehem- Site Number : 8400031

    Bethlehem, Pennsylvania, 18017-9412

    Recruiting

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

    Beverly Hills, California, 90211

    Recruiting

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

    Chevy Chase, Maryland, 20815

    Recruiting

  • Retina Foundation of the Southwest- Site Number : 8400001

    Dallas, Texas, 75231

    Recruiting

  • Texas Retina Associates - Dallas- Site Number : 8400006

    Dallas, Texas, 75231

    Recruiting

  • The Retina Partners- Site Number : 8400040

    Encino, California, 91436

    Recruiting

  • Erie Retina Research- Site Number : 8400035

    Erie, Pennsylvania, 16505

    Recruiting

  • Oregon Retina- Site Number : 8400017

    Eugene, Oregon, 97401

    Recruiting

  • Vitreo Retinal Associates - Gainesville- Site Number : 8400004

    Gainesville, Florida, 32607

    Recruiting

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

    Hagerstown, Maryland, 21740

    Recruiting

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400016

    Ladson, South Carolina, 29456

    Recruiting

  • Charleston Neuroscience Institute - Ladson- Site Number : 8400046

    Ladson, South Carolina, 29456

    Recruiting

  • University Retina - Lemont- Site Number : 8400005

    Lemont, Illinois, 60439

    Recruiting

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

    Oxnard, California, 93036

    Recruiting

  • Associated Retina Consultants - Peoria- Site Number : 8400011

    Peoria, Arizona, 85381

    Recruiting

  • Sierra Eye Associates- Site Number : 8400021

    Reno, Nevada, 89502

    Recruiting

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

    Sacramento, California, 95825

    Recruiting

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

    San Antonio, Texas, 78240

    Recruiting

  • Retina Macula Institute of Arizona- Site Number : 8400028

    Scottsdale, Arizona, 85255

    Recruiting

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

    Southlake, Texas, 76092

    Recruiting

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

    St. Petersburg, Florida, 33711

    Recruiting

  • East Florida Eye Institute- Site Number : 8400038

    Stuart, Florida, 34994

    Recruiting

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

    Torrance, California, 90503

    Recruiting

  • Retina Specialist- Site Number : 8400055

    Towson, Maryland, 21204

    Recruiting

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

    Wake Forest, North Carolina, 27587-3803

    Recruiting

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

    Walnut Creek, California, 94598

    Recruiting

Other trials in United States

Australia3 sites, 3 recruiting

  • Investigational Site Number : 0360002

    Adelaide, South Australia, 5000

    Recruiting

  • Investigational Site Number : 0360001

    East Melbourne, Victoria, 3002

    Recruiting

  • Investigational Site Number : 0360003

    Sydney, New South Wales, 2000

    Recruiting

Other trials in Australia

United Kingdom1 site, 1 recruiting

  • Investigational Site Number : 8260001

    London, W1G 9AX

    Recruiting

Other trials in United Kingdom

About this study

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

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 tested
SAR446597, Sham Comparator
Medical subject headings
Geographic Atrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SAR446597Drug

    Intravitreal injection

  • Sham ComparatorDrug

    Sham injection

Study groups in NCT07215234
Study groupRoleWhat they receive
Part I - SAR446597 open-label (OL)ExperimentalParticipants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants.
Receives: Drug: SAR446597
Part II - SAR446597 Dose AExperimentalParticipants will receive SAR at a dose specified for each arm.
Receives: Drug: SAR446597
Part II - SAR446597 Dose BExperimentalParticipants will receive SAR at a dose specified for each arm.
Receives: Drug: SAR446597
Part II - Sham controlSham comparatorParticipants will receive Sham at a dose specified for each arm.
Receives: Drug: Sham Comparator

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Day 1 to Week 104

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

    Measured: Day 1 to Week 104

Secondary outcomes (4)

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

    Measured: 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

    Measured: Baseline, Week 52, Week 104

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

    Measured: Baseline, Week 52, Week 104

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

    Measured: Week 260 or End of Study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2025
  2. Study start9 Oct 2025
  3. Primary completion13 Oct 2027 (estimated)
  4. Study completion22 Jul 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
104 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07215234
Sponsor's protocol ID
DFI18231
Other IDs
2025-524508-31, 2025
Status last verified
Oct 2026
First submitted
1 Oct 2025
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in