Neovascular Age-related Macular Degeneration
Conditions
Brief 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. 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.
Interventions
BIOLOGICALSAR402663
Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection
DRUGDiluent
Pharmaceutical form:Liquid solution-Route of administration:Intravitreal injection
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Part I is an open-label study. Part II is partially masked in which participants, Investigators, and outcomes assessors including reading center (RC) are masked to study intervention. The Sponsor is not masked. Masking will be maintained until all participants reach 52 weeks of follow up after SAR402663 dose.
Intervention model description
Part I is nonrandomized sequential dose escalation and Part II is randomized parallel assignment
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants with any clinically significant changes in vital signs | Day 1 to Week 52 |
| Incidence and severity of ocular treatment emergent adverse event (TEAEs) | Day 1 to Week 52 |
| Incidence and severity of ocular treatment emergent serious adverse event (TESAEs) | Day 1 to Week 52 |
| Incidence and severity of non-ocular TEAEs | Day 1 to Week 52 |
| Incidence and severity of non-ocular TESAEs | Day 1 to Week 52 |
| Number of participants with any clinically significant changes in laboratory variables | Day 1 to Week 52 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants not requiring supplemental anti-vascular endothelial growth factor (VEGF) therapy | Day 1 to Week 52 and Week 8 to Week 52 | — |
| Change from baseline in BCVA using the ETDRS letter score | 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). |
| Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline | Baseline, Week 52 | — |
| Change from baseline in central subfield thickness (CST), measured by spectral domain optical coherence tomography (SD-OCT) | Baseline, Week 52 | — |
| Annualized injection rates of anti-VEGF therapy | Day 1 to Week 52 | — |
Countries
United States
Contacts
Primary ContactTrial Transparency email recommended (Toll free for US & Canada)
Outcome results
None listed