A Safety and Efficacy Study of One-time SAR402663 in Adults With Neovascular Age-related Macular Degeneration
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorSanofi
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- SAR402663
- Diluent
Treatment groups
66 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov