Trial · NCT02753400
Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy
NCT02753400, 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. Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy. Trials, record NCT02753400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02753400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Effects of Emixustat Hydrochloride in Subjects With Proliferative Diabetic Retinopathy
- NCT number
- NCT02753400
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 24 participants, actual
- Lead sponsor
- Kubota Vision Inc.
- Conditions
- Proliferative Diabetic Retinopathy
- Interventions
- emixustat hydrochloride, Placebo
- First posted
- 2016-04-27
- Last updated
- 2021-05-19
- Results first posted
- 2021-04-27
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Baseline and 12 weeks | All values for IL-1β were below the lower limit of detection and were recorded as zero. Tests for IP-10 and MCP-1 failed accuracy and stability testing during assay development and were dropped from the study. The assay for PDGF-AA could not be developed.and results were not reported. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Baseline and 12 weeks | Not all subjects had primary endpoint end-of-treatment data. | pg/ml | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Emixustat Hydrochloride | IL-6, change from baseline | 45.6 | Standard Deviation 137.1 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Placebo | IL-6, change from baseline | 4.9 | Standard Deviation 12.6 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Emixustat Hydrochloride | IL-8, change from baseline | 4.2 | Standard Deviation 5.1 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Placebo | IL-8, change from baseline | 2.6 | Standard Deviation 4.6 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Emixustat Hydrochloride | TGFβ-1, change from baseline | -19.9 | Standard Deviation 32.4 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Placebo | TGFβ-1, change from baseline | -17.5 | Standard Deviation 43.7 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Emixustat Hydrochloride | VEGF, change from baseline | -38.0 | Standard Deviation 115.1 | pg/ml |
| Change in Aqueous Humor Concentration of the Following Biomarkers:IL-6, IL-8, IP-10, PDGF-AA, TGFβ-1, MCP-1, IL-1β, and VEGF, to be Reported in pg/mL Values | Placebo | VEGF, change from baseline | -24.8 | Standard Deviation 277.2 | pg/ml |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Emixustat Hydrochloride | 12 | |
| Overall Study | STARTED | Placebo | 12 | |
| Overall Study | COMPLETED | Emixustat Hydrochloride | 7 | |
| Overall Study | COMPLETED | Placebo | 11 | |
| Overall Study | NOT COMPLETED | Emixustat Hydrochloride | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 1 |
Source ClinicalTrials.gov
Adverse events142
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 Hydrochloride | 9 | 12 | |
| other | DELAYED DARK ADAPTATION | Eye disorders | Placebo | 1 | 11 | |
| other | BLINDNESS DAY | Eye disorders | Emixustat Hydrochloride | 4 | 12 | |
| other | BLINDNESS DAY | Eye disorders | Placebo | 3 | 11 | |
| other | VISION BLURRED | Eye disorders | Emixustat Hydrochloride | 1 | 12 | |
| other | VISION BLURRED | Eye disorders | Placebo | 6 | 11 | |
| other | VISUAL IMPAIRMENT | Eye disorders | Emixustat Hydrochloride | 6 | 12 | |
| other | VISUAL IMPAIRMENT | Eye disorders | Placebo | 1 | 11 | |
| other | VITREOUS FLOATERS | Eye disorders | Emixustat Hydrochloride | 4 | 12 | |
| other | VITREOUS FLOATERS | Eye disorders | Placebo | 2 | 11 |
1 to 10 of 142Source ClinicalTrials.gov
See all 142 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Emixustat Hydrochloride | 0 | 12 |
| Total, all-cause mortality | Placebo | 0 | 11 |
| Total, other adverse events | Emixustat Hydrochloride | 12 | 12 |
| Total, other adverse events | Placebo | 9 | 11 |
| Total, serious adverse events | Emixustat Hydrochloride | 0 | 12 |
| Total, serious adverse events | Placebo | 2 | 11 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32852613 | 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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Emixustat Hydrochloride vs Placebo: deaths from any cause | Trial comparisons |
| Emixustat Hydrochloride vs Placebo: serious adverse events | Trial comparisons |
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/NCT02753400
GET https://conductscience.org/api/trials/v1/NCT02753400/events?page=2