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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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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
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
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 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

Other trials in United States

United Kingdom2 sites

  • Investigational Site Number : 8260027

    Liverpool, L7 8XP

  • Investigational Site Number : 8260024

    London, Westminster, W1G 7LB

Other trials in United Kingdom

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 groups in NCT06660667
Study groupRoleWhat they receive
Part I - SAR402663 open-label (OL)ExperimentalParticipants 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 AExperimentalParticipants will receive a single dose of SAR402663 on Day 1.
Receives: Biological: SAR402663; Drug: Diluent
Part II - SAR402663 Dose BExperimentalParticipants 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.

  1. Incidence and severity of ocular treatment emergent adverse event (TEAEs)

    Measured: Day 1 to Week 52

  2. Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)

    Measured: Day 1 to Week 52

  3. Incidence and severity of non-ocular TEAEs

    Measured: Day 1 to Week 52

  4. Incidence and severity of non-ocular TESAEs

    Measured: Day 1 to Week 52

  5. Number of participants with any clinically significant changes in laboratory variables

    Measured: Day 1 to Week 52

  6. Number of participants with any clinically significant changes in vital signs

    Measured: Day 1 to Week 52

Secondary outcomes (5)

  1. 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

  2. Annualized injection rates of anti-VEGF therapy

    Measured: Day 1 to Week 52

  3. 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

  4. Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline

    Measured: Baseline, Week 52

  5. 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.

  1. First posted28 Oct 2024
  2. Study start21 Nov 2024
  3. Primary completion18 May 2027 (estimated)
  4. Study completion30 Jun 2031 (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
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)
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

Questions about this trial

What is this clinical trial studying?

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.

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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in United States, 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. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of ocular treatment emergent adverse event (TEAEs) (time frame: Day 1 to Week 52). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06660667.

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 16 Jul 2026.

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