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Visual Cycle Modulator

Emixustat for Stargardt Disease (SeaSTAR Trial)

Phase 3
Waitlist Available
Research Sponsored by Kubota Vision Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Pivotal Trial

Summary

This trial is testing a drug called emixustat hydrochloride to see if it can slow down vision loss in people with Stargardt disease. The drug works by blocking an enzyme that helps produce harmful substances in the eye, which can damage cells and lead to vision problems.

Eligible Conditions
  • Stargardt Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Mean Rate of Change in Total Area of Macular Atrophy, as Measured by Fundus Autofluorescence (FAF)
Secondary study objectives
Mean change from baseline in mean outer nuclear layer thickness on OCT
Mean change in best-corrected Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity letter score
Mean change in contrast sensitivity
+8 more

Side effects data

From 2022 Phase 3 trial • 194 Patients • NCT03772665
2%
neoplasm
1%
agina pectoris
1%
atrial fibrillation
1%
Infections and infestations
1%
Visual disorder
1%
Injury, posioning and procedural
1%
Nervous system disorder
1%
Vascular disorder
1%
Visual acuity reduced
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Emixustat

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: EmixustatExperimental Treatment1 Intervention
10 mg
Group II: PlaceboPlacebo Group1 Intervention
Includes identical tablets with only inactive ingredients (0 mg).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Emixustat
2019
Completed Phase 3
~220

Find a Location

Who is running the clinical trial?

Food and Drug Administration (FDA)FED
181 Previous Clinical Trials
1,548,584 Total Patients Enrolled
Kubota Vision Inc.Lead Sponsor
19 Previous Clinical Trials
2,042 Total Patients Enrolled
1 Trials studying Stargardt Disease
23 Patients Enrolled for Stargardt Disease
Jeff Gregory, MDStudy DirectorVP of Clinical Development, Acucela
3 Previous Clinical Trials
125 Total Patients Enrolled
~28 spots leftby Nov 2025
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