RECRUITING

A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-11-21
Study Completion:2031-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06660667

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 50 and 90 years of age
  2. * Participants with diagnosis of macular neovascularization secondary to age-related macular degeneration (nAMD)
  3. * 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
  4. * Current or previous use of anti-vascular endothelial growth factor (VEGF) treatment in the study eye
  5. * Demonstrated a response to anti-VEGF treatment
  1. * Any condition in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments
  2. * History of active ocular infection in the study eye in 6 months prior to screening
  3. * Active uncontrolled glaucoma in the study eye
  4. * History of uveitis in either eye
  5. * Current use of ocular corticosteroids in the study eye
  6. * Previous gene therapy
  7. * Any significant poorly controlled illness that would preclude study compliance and follow up

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
Contact-US@sanofi.com

Study Locations (Sites)

Site # 8400011
Phoenix, Arizona, 85020
United States
Site # 8400023
Beverly Hills, California, 90211
United States
Site # 8400004
Gainesville, Florida, 32607
United States
Site # 8400002
St. Petersburg, Florida, 33711
United States
Site # 8400005
Lemont, Illinois, 60439
United States
Site # 8400003
Hagerstown, Maryland, 21740
United States
Site # 8400009
Boston, Massachusetts, 02114-2517
United States
Site # 8400021
Reno, Nevada, 89502
United States
Site # 8400017
Eugene, Oregon, 97401
United States
Site # 8400018
Germantown, Tennessee, 38138
United States
Site # 8400015
Austin, Texas, 78705
United States
Site # 8400006
Dallas, Texas, 75231
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-11-21
Study Completion Date2031-06-30

Study Record Updates

Study Start Date2024-11-21
Study Completion Date2031-06-30

Terms related to this study

Additional Relevant MeSH Terms

  • Neovascular Age-related Macular Degeneration