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

Condition(s) studied

Investigational drug(s) / intervention(s)

SAR402663: Pharmaceutical form:Liquid formulation-Route of administration:Intravitreal injection

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

Study 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.

Eligibility

Primary outcome measure(s)

• 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
• Number of participants with any clinically significant changes in vital signs — Day 1 to Week 52

Trial sites (26)

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