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NCT Number: NCT06660667

A Safety and Efficacy Study of One-time SAR402663 in Adults 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:

* 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neovascular Age-related Macular Degeneration

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Investigational Site Number : 8260024, London, Westminster, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

SAR402663

Biological

Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection

Diluent

Drug

Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection

Primary outcomes

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

    Time frame: Day 1 to Week 52

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

    Time frame: Day 1 to Week 52

  3. Incidence and severity of non-ocular TEAEs

    Time frame: Day 1 to Week 52

  4. Incidence and severity of non-ocular TESAEs

    Time frame: Day 1 to Week 52

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

    Time frame: Day 1 to Week 52

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

    Time frame: Day 1 to Week 52

Secondary outcomes

  1. Percentage of participants not requiring supplemental anti- vascular endothelial growth factor (VEGF) therapy

    Time frame: Day 1 to Week 52 and Week 8 to Week 52

  2. Annualized injection rates of anti-VEGF therapy

    Time frame: Day 1 to Week 52

  3. Change from baseline in BCVA using the ETDRS letter score

    Time frame: Baseline, Week 52

    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).

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

    Time frame: Baseline, Week 52

  5. Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT)

    Time frame: Baseline, Week 52

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2027
Study completion
2031
First posted
Oct 28, 2024
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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