Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease

Phase 2

Completed

• Conditions: Macular Atrophy; Stargardt Disease
• Interventions: Drug: Emixustat

• Registration Number: NCT03033108
• Lead Sponsor: Kubota Vision Inc.

Brief Summary

This is a pharmacodynamics study of emixustat hydrochloride in subjects with macular atrophy secondary to Stargardt disease.

Detailed Description

This is a multicenter, randomized, masked study to characterize the pharmacodynamics, safety and tolerability of emixustat in subjects with macular atrophy secondary to Stargardt disease.

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2017-01-20
• Study First Submitted QC: 2017-01-24
• Study First Posted: 2017-01-26
• Primary Completion: 2017-11
• Study Completion: 2017-12
• Results First Submitted: 2021-03-31
• Results First Submitted QC: 2021-03-31
• Status Verified: 2021-04
• Results First Posted: 2021-04-27
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Emixustat Dose 1	Emixustat	lowest dose of once-daily oral emixustat
Emixustat Dose 3	Emixustat	highest dose of once-daily oral emixustat
Emixustat Dose 2	Emixustat	middle dose of once-daily oral emixustat

Primary Outcome Measures

Name	Time	Method
Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram	Baseline and 1 month	Percent suppression compared to baseline of rod b-wave amplitude recovery after a photobleaching light.

Secondary Outcome Measures

Name	Time	Method
Percentage of Subjects With Adverse Events, by Severity and Seriousness	1 month	Assessment of safety profile