Health TrialsbyHealthPanel

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

ConditionNeovascular 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

This trial does not accept healthy volunteers

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

Design model

Sequential

Treatments tested in this trial

  • SAR402663

    Biological/Vaccine

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

  • Diluent

    Drug

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

Treatment groups

66 Participants
are divided into 3 treatment groups
Group A: Part I - SAR402663 open-label (OL)Experimental treatment 2 interventions
Group B: Part II - SAR402663 Dose AExperimental treatment 2 interventions
Group C: Part II - SAR402663 Dose BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Incidence and severity of ocular treatment emergent adverse event (TEAEs)

Time frame
Day 1 to Week 52
2

Incidence and severity of ocular treatment emergent serious adverse event (TESAEs)

Time frame
Day 1 to Week 52
3

Incidence and severity of non-ocular TEAEs

Time frame
Day 1 to Week 52
4

Incidence and severity of non-ocular TESAEs

Time frame
Day 1 to Week 52

Secondary outcomes

1

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
2

Annualized injection rates of anti-VEGF therapy

Time frame
Day 1 to Week 52
3

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
4

Percentage of participants not losing more than or equal to 15 ETDRS letters from baseline

Time frame
Baseline, Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sanofi

Lead sponsor

Source ClinicalTrials.gov
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