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Trial · NCT03033108

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

NCT03033108, Phase 2, Completed, Kubota Vision Inc.; results first posted 2021-04-27

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease. Trials, record NCT03033108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03033108

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Pharmacodynamic Study of Emixustat Hydrochloride in Subjects With Macular Atrophy Secondary to Stargardt Disease
NCT number
NCT03033108
Status
Completed
Phases
Phase 2
Enrollment
23 participants, actual
Lead sponsor
Kubota Vision Inc.
Conditions
Stargardt Disease, Macular Atrophy
Interventions
Emixustat
First posted
2017-01-26
Last updated
2021-05-19
Results first posted
2021-04-27
Limitations and caveats
Small sample size and inherent, significant intersubject and intrasubject variability observed in electroretinography.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange in Electrical Response of the Retina to a Flash of Light, as Measured by ElectroretinogramBaseline and 1 monthPercent suppression compared to baseline of rod b-wave amplitude recovery after a photobleaching light.
SecondaryPercentage of Subjects With Adverse Events, by Severity and Seriousness1 monthAssessment of safety profile

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYChange in Electrical Response of the Retina to a Flash of Light, as Measured by ElectroretinogramBaseline and 1 monthSubjects with evaluable ERGs at both Baseline and Month 1percent suppressionMEDIAN
SECONDARYPercentage of Subjects With Adverse Events, by Severity and Seriousness1 monthParticipantsCOUNT_OF_PARTICIPANTS

Results by group18

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change in Electrical Response of the Retina to a Flash of Light, as Measured by ElectroretinogramEmixustat Dose 1-12.23Full Range -41.0 to 54.7percent suppression
Change in Electrical Response of the Retina to a Flash of Light, as Measured by ElectroretinogramEmixustat Dose 268.00Full Range 1.0 to 91.5percent suppression
Change in Electrical Response of the Retina to a Flash of Light, as Measured by ElectroretinogramEmixustat Dose 396.69Full Range 64.9 to 100.0percent suppression
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 1Subjects with 1 or more adverse events6Participants
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 2Subjects with 1 or more adverse events8Participants
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 3Subjects with 1 or more adverse events6Participants
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 1Subjects with 1 or more mild adverse events5Participants
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 2Subjects with 1 or more mild adverse events5Participants
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 3Subjects with 1 or more mild adverse events4Participants
Percentage of Subjects With Adverse Events, by Severity and SeriousnessEmixustat Dose 1Subjects with 1 or more moderate adverse events1Participants

Participant flow9

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDEmixustat Dose 17
Overall StudySTARTEDEmixustat Dose 29
Overall StudySTARTEDEmixustat Dose 37
Overall StudyCOMPLETEDEmixustat Dose 17
Overall StudyCOMPLETEDEmixustat Dose 28
Overall StudyCOMPLETEDEmixustat Dose 37
Overall StudyNOT COMPLETEDEmixustat Dose 10
Overall StudyNOT COMPLETEDEmixustat Dose 21
Overall StudyNOT COMPLETEDEmixustat Dose 30

Adverse events69

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
otherDelayed Dark AdaptationEye disordersEmixustat Dose 117
otherDelayed Dark AdaptationEye disordersEmixustat Dose 269
otherDelayed Dark AdaptationEye disordersEmixustat Dose 347
otherErythropsiaEye disordersEmixustat Dose 117
otherErythropsiaEye disordersEmixustat Dose 239
otherErythropsiaEye disordersEmixustat Dose 317
otherVision blurredEye disordersEmixustat Dose 127
otherVision blurredEye disordersEmixustat Dose 219
otherVision blurredEye disordersEmixustat Dose 317
otherPhotophobiaEye disordersEmixustat Dose 117

Adverse event totals9

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityEmixustat Dose 107
Total, all-cause mortalityEmixustat Dose 209
Total, all-cause mortalityEmixustat Dose 307
Total, other adverse eventsEmixustat Dose 167
Total, other adverse eventsEmixustat Dose 289
Total, other adverse eventsEmixustat Dose 377
Total, serious adverse eventsEmixustat Dose 107
Total, serious adverse eventsEmixustat Dose 209
Total, serious adverse eventsEmixustat Dose 307

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMIDListed as
33214244DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03033108

GET https://conductscience.org/api/trials/v1/NCT03033108/events?page=2