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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
66
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Site # 8400011
Phoenix, Arizona, United States
RECRUITINGSite # 8400028
Scottsdale, Arizona, United States
RECRUITINGSite # 8400023
Beverly Hills, California, United States
RECRUITINGSite # 8400004
Gainesville, Florida, United States
RECRUITINGSite # 8400002
St. Petersburg, Florida, United States
RECRUITINGSite # 8400010
Augusta, Georgia, United States
RECRUITINGSite # 8400005
Lemont, Illinois, United States
RECRUITINGSite # 8400003
Hagerstown, Maryland, United States
RECRUITINGSite # 8400009
Boston, Massachusetts, United States
RECRUITINGSite # 8400021
Reno, Nevada, United States
RECRUITING...and 8 more locations
Incidence and severity of ocular treatment emergent adverse event (TEAEs)
Time frame: Day 1 to Week 52
Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)
Time frame: Day 1 to Week 52
Incidence and severity of non-ocular TEAEs
Time frame: Day 1 to Week 52
Incidence and severity of non-ocular TESAEs
Time frame: Day 1 to Week 52
Number of participants with any clinically significant changes in laboratory variables
Time frame: Day 1 to Week 52
Number of participants with any clinically significant changes in vital signs
Time frame: Day 1 to Week 52
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
Annualized injection rates of anti-VEGF therapy
Time frame: 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).
Time frame: Baseline, Week 52
Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline
Time frame: Baseline, Week 52
Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT)
Time frame: Baseline, Week 52
Trial Transparency email recommended (Toll free for US & Canada)
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