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A Safety and Efficacy Study of a One-time Intravitreal Injection of SAR446597 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

ConditionGeographic Atrophy
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorSanofi

About this trial

This is a sequential Phase 1/2, two-part, multicenter study on safety, tolerability, and efficacy of one-time intravitreal SAR446597 for the treatment of participants with Geographic Atrophy (GA) secondary to Age-related Macular Degeneration (AMD).

The core phase duration will be approximately 2 years for each participant. An Extended Follow-Up (EFU) phase of 3 years follows the core phase.

The treatment is a one-time intravitreal injection of SAR446597 (or sham as applicable in Part II).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60 years old or above

Participants with diagnosis of GA secondary to age-related macular degeneration (AMD)

Study eye with best corrected visual acuity (BCVA) ETDRS Snellen equivalent for dose escalation (Part I) between 20/40 and 20/320 and for expansion (Part II) equal or better than 20/200

Study eye with GA lesion measuring between 2.5 and 17.5 mm2 for dose escalation (Part I) and between 2.5 and 14.0 mm2 for expansion (Part II). For multifocal disease, study eye with at least one single lesion of more than 1.25mm2 for both Part I and Part II

Disqualifiers

GA in the study eye caused by a disease different than AMD

Presence of neovascularization or a history of treatment with an anti vascular endothelial growth factor agent in the study eye

Any condition or treatment (ocular or systemic) or medical or surgical history in the study eye that may prevent visual acuity improvement or interfere with ocular safety or efficacy assessments

Current or history of systemic complement targeting treatment in the past 12 months

Trial design

Design model

Sequential

Treatments tested in this trial

  • SAR446597

    Drug

    Intravitreal injection

  • Sham Comparator

    Drug

    Sham injection

Treatment groups

104 Participants
are divided into 4 treatment groups
Group A: Part I - SAR446597 open-label (OL)Experimental treatment 1 intervention
Group B: Part II - SAR446597 Dose AExperimental treatment 1 intervention
Group C: Part II - SAR446597 Dose BExperimental treatment 1 intervention
Group D: Part II - Sham controlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence and severity of ocular and non-ocular treatment-emergent adverse events (TEAEs)

Time frame
Day 1 to Week 104
2

Incidence and severity of ocular and non-ocular treatment-emergent serious adverse events (TESAEs)

Time frame
Day 1 to Week 104

Secondary outcomes

1

Change in square root-transformed (mm) and untransformed area (mm2) of GA

Time frame
Baseline, Week 52, Week 104
2

Change in best-corrected visual acuity (BCVA) from baseline to Week 52 and Week 104 following SAR446597 administration measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) chart

Time frame
Baseline, Week 52, Week 104
3

Percentage of participants without loss of BCVA of ≥15 ETDRS letters from baseline in the study eye

Time frame
Baseline, Week 52, Week 104
4

Incidence and severity of ocular and non-ocular TEAEs and TESAEs including clinically significant changes in safety parameters

Time frame
Week 260 or End of Study

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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