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A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)

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ClinicalTrials.gov Identifier: NCT05038020
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : October 27, 2021
Sponsor:
Information provided by (Responsible Party):
Alkahest, Inc.

Brief Summary:
A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: AKST4290 Drug: Placebo Phase 2

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Actual Study Start Date : August 17, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : October 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: AKST4290
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
Drug: AKST4290
Oral AKST4290

Placebo Comparator: Placebo
Subjects will receive matching Placebo, twice daily, for 24 weeks
Drug: Placebo
Oral Placebo




Primary Outcome Measures :
  1. To investigate the efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline. [ Time Frame: Baseline to Week 24 ]

Secondary Outcome Measures :
  1. 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 ]
  2. To assess the proportion of participants progressing to (or worsening of) CI-DME, PDR, and/or anterior-segment neovascularization (ASNV). [ Time Frame: Baseline to Week 28 ]
  3. To assess the time to event of CI-DME, PDR, and/or ASNV requiring treatment. [ Time Frame: Baseline to Week 28 ]
  4. To assess the overall safety of AKST4290 assessed by the incidence and intenisty of adverse events. [ Time Frame: Baseline to Week 28 ]
  5. To assess the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values such as estimated glomerular filtration rate (eGFR) and urine albumin to creatinine ratio (UACR). [ Time Frame: Baseline to Week 28 ]
  6. To evaluate the changes from Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) questionnaire. WPAI outcomes are expressed as percentages, with higher numbers indicating greater impairment and less productivity. [ Time Frame: Baseline to Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age ≥ 18 years.
  2. Type 1 or type 2 DM.
  3. BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.
  4. Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).

Exclusion Criteria:

  1. Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.
  2. PRP or grid laser within 1000 microns of the foveal center.
  3. CI-DME on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).
  4. Prior Intraocular of periocular steroid Injection
  5. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.
  6. History of vitreoretinal surgery.
  7. 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.
  8. History of DME or DR treatment with laser or intraocular injections of medication.
  9. Medical history or condition that, in the opinion of the investigator would preclude participation in the study.
  10. Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).
  11. 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).
  12. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05038020


Contacts
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Contact: Alkahest Clinical Trials 650-801-0474 trials@alkahest.com

Locations
Show Show 17 study locations
Sponsors and Collaborators
Alkahest, Inc.
Investigators
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Study Director: Alkahest Medical Monitor Alkahest, Inc.
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Responsible Party: Alkahest, Inc.
ClinicalTrials.gov Identifier: NCT05038020    
Other Study ID Numbers: AKST4290-231
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alkahest, Inc.:
CCR3 inhibition
Diabetic Retinopathy
Oral Treatment
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases