Neovascular Age-related Macular DegenerationPhase 1/2NCT06660667
A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
A Phase 1/2 study testing SAR402663 and Diluent in people with Neovascular Age-related Macular Degeneration, run by Sanofi at 26 sites in 2 countries.
Trial summary
This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Neovascular Age-related Macular Degeneration
- What is being tested?
- SAR402663 and Diluent
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 26 sitesin 2 countries
- Study dates
- 21 Nov 2024to 30 Jun 2031
- 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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Between 50 and 90 years of age
- Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
- Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/32 and 20/400 and for expansion (Part II) between 20/25 and 20/200
- Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
- Demonstrated a response to anti-VEGF treatment
Who cannot join
- Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
- History of active ocular infection in the study eye in 6 months prior to screening
- Active uncontrolled glaucoma in the study eye
- History of uveitis in either eye
- Current use of ocular corticosteroids in the study eye
- Previous gene therapy
- 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 potential participation in a clinical trial.
Trial locations and contacts
26 sites in 2 countries.
26 sites in 2 countries
United States24 sites
Retina Research Institute of Texas- Site Number : 8400008
Abilene, Texas, 79606
Southeast Retina Center- Site Number : 8400010
Augusta, Georgia, 30909
Austin Research Center for Retina- Site Number : 8400015
Austin, Texas, 78705
Austin Clinical Research - Austin - Anderson Mill Road- Site Number : 8400007
Austin, Texas, 78750
California Retina Consultants - Bakersfield- Site Number : 8400001
Bakersfield, California, 93309
Mid Atlantic Retina- Site Number : 8400032
Bethlehem, Pennsylvania, 18017-9412
Retina-Vitreous Associates Medical Group - Beverly Hills- Site Number : 8400023
Beverly Hills, California, 90211
Ophthalmic Consultants of Boston - Boston- Site Number : 8400009
Boston, Massachusetts, 02114
Texas Retina Associates - Dallas- Site Number : 8400006
Dallas, Texas, 75231
Oregon Retina- Site Number : 8400017
Eugene, Oregon, 97401
Vitreo Retinal Associates - Gainesville- Site Number : 8400004
Gainesville, Florida, 32607
Charles Retina Institution- Site Number : 8400018
Germantown, Tennessee, 38138
Cumberland Valley Retina Consultants - Hagerstown- Site Number : 8400003
Hagerstown, Maryland, 21740
Charleston Neuroscience Institute - Ladson- Site Number : 8400016
Ladson, South Carolina, 29456
University Retina - Lemont- Site Number : 8400005
Lemont, Illinois, 60439
Associated Retina Consultants - Phoenix- Site Number : 8400011
Phoenix, Arizona, 85020
Sierra Eye Associates- Site Number : 8400021
Reno, Nevada, 89502
Medical Center Ophthalmology Associates- Site Number : 8400030
San Antonio, Texas, 78240
Retinal Consultants of Texas - San Antonio- Site Number : 8400012
San Antonio, Texas, 78240
Retina Macula Institute of Arizona- Site Number : 8400028
Scottsdale, Arizona, 85255
Retina Vitreous Associates of Florida - St. Petersburg- Site Number : 8400002
St. Petersburg, Florida, 33711
Retina Consultants of Texas - The Woodlands- Site Number : 8400019
The Woodlands, Texas, 77384
Retina Specialist- Site Number : 8400020
Towson, Maryland, 21204
North Carolina (Nc) Retina Associates - Wake Forest Office- Site Number : 8400033
Wake Forest, North Carolina, 27587-3803
United Kingdom2 sites
Investigational Site Number : 8260027
Liverpool, L7 8XP
Investigational Site Number : 8260024
London, Westminster, W1G 7LB
About this study
Official title: A Phase 1/2 Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, and Efficacy of One-time Intravitreal Dose of SAR402663 in Participants With Neovascular Age-related Macular Degeneration
This is a Phase 1/Phase 2 multicenter study to evaluate the safety and efficacy of a one-time single-eye intravitreal dose of SAR402663 in participants with neovascular age-related macular degeneration.
Participants will be enrolled in one of 2 parts:
Read more
- In Part I (dose escalation), multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants
- In Part II (dose expansion), participants will be randomized to receive one of two dose levels selected based on data from Part I. Participants, investigators and outcomes assessors will be masked to dose.
After receiving one-time dose of SAR402663, participants will undergo regular assessments over 12 months. Following this, participants will enter an extended follow-up (EFU) phase for the assessment of safety and durability of clinical activity of SAR402663 through Year 5.
- Being tested
- SAR402663, Diluent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SAR402663Biological
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
DiluentDrug
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| Part I - SAR402663 open-label (OL) | Experimental | Participants will receive a single dose of SAR402663 on Day 1. Multiple dose levels of SAR402663 will be evaluated in successive cohorts of participants. Receives: Biological: SAR402663; Drug: Diluent |
| Part II - SAR402663 Dose A | Experimental | Participants will receive a single dose of SAR402663 on Day 1. Receives: Biological: SAR402663; Drug: Diluent |
| Part II - SAR402663 Dose B | Experimental | Participants will receive a single dose of SAR402663 on Day 1. Receives: Biological: SAR402663; Drug: Diluent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Measured: Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Measured: Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Measured: Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Measured: Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Measured: Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Measured: Day 1 to Week 52
Secondary outcomes (5)
Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy
Measured: Day 1 to Week 52 and Week 8 to Week 52
Annualized injection rates of anti-VEGF therapy
Measured: Day 1 to Week 52
Change from baseline in BCVA using the ETDRS letter score
Visual function of the study eye was assessed at a distance of 4 meters using the best corrected visual acuity (BCVA) early treatment diabetic retinopathy study (ETDRS) letter score. BCVA scale range is 0 (worst score) to 100 (best score).
Measured: Baseline, Week 52
Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline
Measured: Baseline, Week 52
Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT)
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start21 Nov 2024
- Primary completion18 May 2027 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neovascular Age-related Macular DegenerationStudies 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
- Model description
- Part I is nonrandomized sequential dose escalation and Part II is randomized parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06660667
- Sponsor's protocol ID
- DFI17940
- Other IDs
- U1111-1299-1827
- Status last verified
- Jul 2026
- First submitted
- 25 Oct 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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