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.
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
- Are there results?
- Not yet: the study is under way
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
35 sites in 3 countries
United States31 sites, 31 recruiting
- 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
Australia3 sites, 3 recruiting
- 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
United Kingdom1 site, 1 recruiting
- Recruiting
Investigational Site Number : 8260001
London, W1G 9AX
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).
- Conditions
- Geographic Atrophy
- 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 group | Role | What they receive |
|---|---|---|
| Part I - SAR446597 open-label (OL) | Experimental | Participants 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 A | Experimental | Participants will receive SAR at a dose specified for each arm. Receives: Drug: SAR446597 |
| Part II - SAR446597 Dose B | Experimental | Participants will receive SAR at a dose specified for each arm. Receives: Drug: SAR446597 |
| Part II - Sham control | Sham comparator | Participants 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.
Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)
Measured: Day 1 to Week 104
Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)
Measured: Day 1 to Week 104
Secondary outcomes (4)
Change in square root-transformed (mm) and untransformed area (mm2) of GA
Measured: 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
Measured: Baseline, Week 52, Week 104
Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye
Measured: Baseline, Week 52, Week 104
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.
- First posted10 Oct 2025
- Study start9 Oct 2025
- Primary completion13 Oct 2027 (estimated)
- Study completion22 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geographic AtrophyStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07215234
- Acronym / sponsor ID
- DFI18231
- Conditions
- Geographic Atrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 9 Oct 2025 (actual)
- Primary completion
- 13 Oct 2027 (estimated)
- Study completion
- 22 Jul 2032 (estimated)
- First posted
- 10 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part I - SAR446597 open-label (OL) | Experimental | Drug: SAR446597Participants will receive SAR at a dose specified for each cohort. Multiple dose levels of SAR446597 will be evaluated in successive cohorts of participants. |
| Part II - SAR446597 Dose A | Experimental | Drug: SAR446597Participants will receive SAR at a dose specified for each arm. |
| Part II - SAR446597 Dose B | Experimental | Drug: SAR446597Participants will receive SAR at a dose specified for each arm. |
| Part II - Sham control | Sham comparator | Drug: Sham ComparatorParticipants will receive Sham at a dose specified for each arm. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SAR446597Intravitreal injection | Drug | Part I - SAR446597 open-label (OL), Part II - SAR446597 Dose A, Part II - SAR446597 Dose B |
| Sham ComparatorSham injection | Drug | Part II - Sham control |
Primary outcome
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
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- DFI18231 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial Transparency email recommended (Toll free for US & Canada) contact
35 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SAR446597 in people with Geographic Atrophy, run by Sanofi at 35 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Australia, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial Transparency email recommended (Toll free for US & Canada) (800-633-1610 ext. option 6, contact-us@sanofi.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs) (time frame: Day 1 to Week 104). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.