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

Sponsor
Alkahest, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05038020
Collaborator
(none)
80
Enrollment
17
Locations
2
Arms
13.5
Anticipated Duration (Months)
4.7
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
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

Study Design

Study Type:
Interventional
Anticipated 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 :
Aug 17, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

ArmIntervention/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

Outcome Measures

Primary Outcome Measures

  1. To investigate the efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline. [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. [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). [Baseline to Week 28]

  3. To assess the time to event of CI-DME, PDR, and/or ASNV requiring treatment. [Baseline to Week 28]

  4. To assess the overall safety of AKST4290 assessed by the incidence and intenisty of adverse events. [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). [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. [Baseline to Week 24]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Site 132PhoenixArizonaUnited States85021
2Site 136PhoenixArizonaUnited States85053
3Site 123GlendaleCaliforniaUnited States91203
4Site 121Huntington BeachCaliforniaUnited States92647
5Site 116ClearwaterFloridaUnited States33761
6Site 117SarasotaFloridaUnited States34239
7Site 118Winter HavenFloridaUnited States33880
8Site 120Oak ForestIllinoisUnited States60452
9Site 133BeaufortSouth CarolinaUnited States29902
10Site 127LadsonSouth CarolinaUnited States29456
11Site 122ArlingtonTexasUnited States76012
12Site 130BellaireTexasUnited States77401
13Site 126HarlingenTexasUnited States78550
14Site 134HoustonTexasUnited States77025
15Site 129KatyTexasUnited States77494
16Site 128San AntonioTexasUnited States78240
17Site 125Salt Lake CityUtahUnited States84107

Sponsors and Collaborators

  • Alkahest, Inc.

Investigators

  • Study Director: Alkahest Medical Monitor, Alkahest, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alkahest, Inc.
ClinicalTrials.gov Identifier:
NCT05038020
Other Study ID Numbers:
  • AKST4290-231
First Posted:
Sep 8, 2021
Last Update Posted:
Oct 27, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Alkahest, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 27, 2021