Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI) (NCT NCT05038020)
NCT ID: NCT05038020
Last Updated: 2023-11-01
Results Overview
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.
TERMINATED
PHASE2
3 participants
Baseline to Week 24
2023-11-01
Participant Flow
The study was terminated early by the Sponsor. At the time of discontinuation, three participants were enrolled and none completed the study.
Participant milestones
| Measure |
AKST4290
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
AKST4290: Oral AKST4290
|
Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
Placebo: Oral Placebo
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
Reasons for withdrawal
| Measure |
AKST4290
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
AKST4290: Oral AKST4290
|
Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
Placebo: Oral Placebo
|
|---|---|---|
|
Overall Study
Early Termination
|
3
|
0
|
Baseline Characteristics
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Baseline to Week 24Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24 or 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 28Population: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 28Population: 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.
The secondary efficacy endpoint is the time to the following vision-threatening event(s) that require treatment: CI-DME, PDR, and/or ASNV
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 28Population: 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.
Safety was assessed based on the number of participants who reported adverse events of mild, moderate or severe intensities.
Outcome measures
| Measure |
AKST4290
n=3 Participants
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
AKST4290: Oral AKST4290
|
Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
Placebo: Oral Placebo
|
|---|---|---|
|
To Assess the Overall Safety of AKST429
AE Intensity - Mild
|
1 Participants
|
0 Participants
|
|
To Assess the Overall Safety of AKST429
AE Intensity - Moderate
|
2 Participants
|
0 Participants
|
|
To Assess the Overall Safety of AKST429
AE Intensity - Severe
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 28Population: 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.
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 \[UACR\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to Week 24Population: 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.
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
Outcome measures
Outcome data not reported
Adverse Events
AKST4290
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AKST4290
n=3 participants at risk
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
AKST4290: Oral AKST4290
|
Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
Placebo: Oral Placebo
|
|---|---|---|
|
Metabolism and nutrition disorders
Diabetes Mellitus
|
33.3%
1/3 • Number of events 1 • The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
|
—
0/0 • The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
|
|
Eye disorders
Vitreous floaters
|
33.3%
1/3 • Number of events 1 • The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
|
—
0/0 • The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
33.3%
1/3 • Number of events 1 • The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
|
—
0/0 • The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.
Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60