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
Cite this record
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
On this page
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.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Percentage of Subjects With Adverse Events, by Severity and Seriousness | 1 month | Assessment of safety profile |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram | Baseline and 1 month | Subjects with evaluable ERGs at both Baseline and Month 1 | percent suppression | MEDIAN |
| SECONDARY | Percentage of Subjects With Adverse Events, by Severity and Seriousness | 1 month | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram | Emixustat Dose 1 | -12.23 | Full Range -41.0 to 54.7 | percent suppression | |
| Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram | Emixustat Dose 2 | 68.00 | Full Range 1.0 to 91.5 | percent suppression | |
| Change in Electrical Response of the Retina to a Flash of Light, as Measured by Electroretinogram | Emixustat Dose 3 | 96.69 | Full Range 64.9 to 100.0 | percent suppression | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 1 | Subjects with 1 or more adverse events | 6 | Participants | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 2 | Subjects with 1 or more adverse events | 8 | Participants | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 3 | Subjects with 1 or more adverse events | 6 | Participants | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 1 | Subjects with 1 or more mild adverse events | 5 | Participants | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 2 | Subjects with 1 or more mild adverse events | 5 | Participants | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 3 | Subjects with 1 or more mild adverse events | 4 | Participants | |
| Percentage of Subjects With Adverse Events, by Severity and Seriousness | Emixustat Dose 1 | Subjects with 1 or more moderate adverse events | 1 | Participants |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Emixustat Dose 1 | 7 | |
| Overall Study | STARTED | Emixustat Dose 2 | 9 | |
| Overall Study | STARTED | Emixustat Dose 3 | 7 | |
| Overall Study | COMPLETED | Emixustat Dose 1 | 7 | |
| Overall Study | COMPLETED | Emixustat Dose 2 | 8 | |
| Overall Study | COMPLETED | Emixustat Dose 3 | 7 | |
| Overall Study | NOT COMPLETED | Emixustat Dose 1 | 0 | |
| Overall Study | NOT COMPLETED | Emixustat Dose 2 | 1 | |
| Overall Study | NOT COMPLETED | Emixustat Dose 3 | 0 |
Source ClinicalTrials.gov
Adverse events69
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Delayed Dark Adaptation | Eye disorders | Emixustat Dose 1 | 1 | 7 | |
| other | Delayed Dark Adaptation | Eye disorders | Emixustat Dose 2 | 6 | 9 | |
| other | Delayed Dark Adaptation | Eye disorders | Emixustat Dose 3 | 4 | 7 | |
| other | Erythropsia | Eye disorders | Emixustat Dose 1 | 1 | 7 | |
| other | Erythropsia | Eye disorders | Emixustat Dose 2 | 3 | 9 | |
| other | Erythropsia | Eye disorders | Emixustat Dose 3 | 1 | 7 | |
| other | Vision blurred | Eye disorders | Emixustat Dose 1 | 2 | 7 | |
| other | Vision blurred | Eye disorders | Emixustat Dose 2 | 1 | 9 | |
| other | Vision blurred | Eye disorders | Emixustat Dose 3 | 1 | 7 | |
| other | Photophobia | Eye disorders | Emixustat Dose 1 | 1 | 7 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Emixustat Dose 1 | 0 | 7 |
| Total, all-cause mortality | Emixustat Dose 2 | 0 | 9 |
| Total, all-cause mortality | Emixustat Dose 3 | 0 | 7 |
| Total, other adverse events | Emixustat Dose 1 | 6 | 7 |
| Total, other adverse events | Emixustat Dose 2 | 8 | 9 |
| Total, other adverse events | Emixustat Dose 3 | 7 | 7 |
| Total, serious adverse events | Emixustat Dose 1 | 0 | 7 |
| Total, serious adverse events | Emixustat Dose 2 | 0 | 9 |
| Total, serious adverse events | Emixustat Dose 3 | 0 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33214244 | DERIVED |
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.
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