- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05038020
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily [b.i.d.]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (NPDR) to severe NPDR.
Participants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85021
- Site 132
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Phoenix, Arizona, United States, 85053
- Site 136
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California
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Glendale, California, United States, 91203
- Site 123
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Huntington Beach, California, United States, 92647
- Site 121
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Florida
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Clearwater, Florida, United States, 33761
- Site 116
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Sarasota, Florida, United States, 34239
- Site 117
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Winter Haven, Florida, United States, 33880
- Site 118
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Illinois
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Oak Forest, Illinois, United States, 60452
- Site 120
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South Carolina
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Beaufort, South Carolina, United States, 29902
- Site 133
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Ladson, South Carolina, United States, 29456
- Site 127
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Texas
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Arlington, Texas, United States, 76012
- Site 122
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Bellaire, Texas, United States, 77401
- Site 130
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Harlingen, Texas, United States, 78550
- Site 126
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Houston, Texas, United States, 77025
- Site 134
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Katy, Texas, United States, 77494
- Site 129
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San Antonio, Texas, United States, 78240
- Site 128
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Utah
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Salt Lake City, Utah, United States, 84107
- Site 125
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 18 years.
- Type 1 or type 2 DM.
- BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
- Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).
Exclusion Criteria:
- Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
- PRP or grid laser within 1000 microns of the foveal center.
- Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
- Prior Intraocular of periocular steroid Injection
- Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
- History of vitreoretinal surgery.
- History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.
- History of DME or DR treatment with laser or intraocular injections of medication.
- Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
- Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
- Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).
- Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AKST4290
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
|
Oral AKST4290
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Placebo Comparator: Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
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Oral Placebo
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
Time Frame: Baseline to Week 24
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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. |
Baseline to Week 24
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
Time Frame: 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. |
Baseline to Week 24 or 28
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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).
Time Frame: Baseline to Week 28
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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.
|
Baseline to Week 28
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To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.
Time Frame: Baseline to Week 28
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The secondary efficacy endpoint is the time to the following vision-threatening event(s) that require treatment: CI-DME, PDR, and/or ASNV
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Baseline to Week 28
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To Assess the Overall Safety of AKST429
Time Frame: Baseline to Week 28
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Safety was assessed based on the number of participants who reported adverse events of mild, moderate or severe intensities.
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Baseline to Week 28
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To Assess the Effect of AKST4290 on Diabetic Kidney Disease
Time Frame: Baseline to Week 28
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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]).
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Baseline to Week 28
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To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.
Time Frame: Baseline to Week 24
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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):
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Baseline to Week 24
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Alkahest Medical Monitor, Alkahest, Inc.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AKST4290-231
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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