Trial · NCT05038020
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
NCT05038020, Phase 2, Terminated, Alkahest, Inc.; results first posted 2023-11-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI). Trials, record NCT05038020. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05038020
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
- NCT number
- NCT05038020
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Alkahest, Inc.
- Conditions
- Diabetic Retinopathy
- Interventions
- AKST4290, Placebo
- First posted
- 2021-09-08
- Last updated
- 2023-11-01
- Results first posted
- 2023-11-01
- Limitations and caveats
This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on low enrollment number, no data is reported in order to protect and maintain participant privacy/confidentiality.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline. | Baseline to Week 24 | The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR. To be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline. The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings. The primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24. |
| Secondary | To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline. | Baseline to Week 24 or 28 | The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR. The DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings. The secondary efficacy endpoint is the proportion of participants with a ≥ 2-step improvement from baseline on the DRSS score as compared with Week 24. |
| Secondary | To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV). | Baseline to Week 28 | The secondary efficacy endpoint is the proportion of participants progressing to the following vision-threatening complications that require treatment: CI-DME, PDR, and/or ASNV as assessed by spectral domain optical coherence tomography (SD-OCT), fundus photography (FP), and fluorescein angiography (FA), as appropriate. The central reading center must confirm progression to CI-DME and PDR before treatment is initiated; progression to ASNV, and subsequent treatment, does not require photo documentation. |
| Secondary | To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment. | Baseline to Week 28 | The secondary efficacy endpoint is the time to the following vision-threatening event(s) that require treatment: CI-DME, PDR, and/or ASNV |
| Secondary | To Assess the Overall Safety of AKST429 | Baseline to Week 28 | Safety was assessed based on the number of participants who reported adverse events of mild, moderate or severe intensities. |
| Secondary | To Assess the Effect of AKST4290 on Diabetic Kidney Disease | Baseline to Week 28 | The secondary efficacy endpoint is the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values over time (eg, estimated glomerular filtration rate \[eGFR\], urine albumin to creatinine ratio \[UACR\]). |
| Secondary | To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire. | Baseline to Week 24 | The WPAI-GH V2.0 is a 6-question survey used to assess the effects of a participant's health problems (i.e., physical or emotional problems or symptoms) on their ability to work and perform regular activities during the past seven days. The WPAI-GH questions will be analyzed as impairment percentages, in which higher percentages indicate greater impairment and less productivity. The following parameters will be calculated (multiply scores by 100 to express in percentages): * Percent of work time missed due to health: Q2 divided by (Q2 plus Q4) * Percent of impairment while working due to health: Q5 divided by 10 * Percent of overall work impairment due to health: Q2 divided by (Q2 plus Q4) plus \[(1 - (Q2 divided by (Q2 plus Q4 ))) multiplied by (Q5 divided by 10)\] * Percent of activity impairment due to health: Q6 divided by 10 |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline. | Baseline to Week 24 | The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline. | Baseline to Week 24 or 28 | The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV). | Baseline to Week 28 | The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment. | Baseline to Week 28 | The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | To Assess the Overall Safety of AKST429 | Baseline to Week 28 | The study was terminated early by the Sponsor. At the time of discontinuation, three participants were enrolled, and all participants were allocated to randomized treatment with AKST4290. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | To Assess the Effect of AKST4290 on Diabetic Kidney Disease | Baseline to Week 28 | The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. | ||
| SECONDARY | To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire. | Baseline to Week 24 | The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality. |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| To Assess the Overall Safety of AKST429 | AKST4290 | AE Intensity - Mild | 1 | Participants | |
| To Assess the Overall Safety of AKST429 | Placebo | AE Intensity - Mild | 0 | Participants | |
| To Assess the Overall Safety of AKST429 | AKST4290 | AE Intensity - Moderate | 2 | Participants | |
| To Assess the Overall Safety of AKST429 | Placebo | AE Intensity - Moderate | 0 | Participants | |
| To Assess the Overall Safety of AKST429 | AKST4290 | AE Intensity - Severe | 0 | Participants | |
| To Assess the Overall Safety of AKST429 | Placebo | AE Intensity - Severe | 0 | Participants |
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 | AKST4290 | 3 | |
| Overall Study | STARTED | Placebo | 0 | |
| Overall Study | COMPLETED | AKST4290 | 0 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | NOT COMPLETED | AKST4290 | 3 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events6
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 | Diabetes Mellitus | Metabolism and nutrition disorders | AKST4290 | 1 | 3 | 1 |
| other | Diabetes Mellitus | Metabolism and nutrition disorders | Placebo | 0 | 0 | 0 |
| other | Vitreous floaters | Eye disorders | AKST4290 | 1 | 3 | 1 |
| other | Vitreous floaters | Eye disorders | Placebo | 0 | 0 | 0 |
| other | Activated partial thromboplastin time prolonged | Investigations | AKST4290 | 1 | 3 | 1 |
| other | Activated partial thromboplastin time prolonged | Investigations | Placebo | 0 | 0 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AKST4290 | 0 | 3 |
| Total, all-cause mortality | Placebo | 0 | 0 |
| Total, other adverse events | AKST4290 | 2 | 3 |
| Total, other adverse events | Placebo | 0 | 0 |
| Total, serious adverse events | AKST4290 | 0 | 3 |
| Total, serious adverse events | Placebo | 0 | 0 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT05038020
GET https://conductscience.org/api/trials/v1/NCT05038020/registered