A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
NCT ID: NCT05038020
Last Updated: 2023-11-01
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
3 participants
INTERVENTIONAL
2021-08-17
2022-04-19
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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
Interventions
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AKST4290
Oral AKST4290
Placebo
Oral Placebo
Eligibility Criteria
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Inclusion Criteria
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
2. PRP or grid laser within 1000 microns of the foveal center.
3. Center-InvolvedI-Diabetic Macular Edema (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.
18 Years
ALL
No
Sponsors
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Alkahest, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Alkahest Medical Monitor
Role: STUDY_DIRECTOR
Alkahest, Inc.
Locations
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Site 132
Phoenix, Arizona, United States
Site 136
Phoenix, Arizona, United States
Site 123
Glendale, California, United States
Site 121
Huntington Beach, California, United States
Site 116
Clearwater, Florida, United States
Site 117
Sarasota, Florida, United States
Site 118
Winter Haven, Florida, United States
Site 120
Oak Forest, Illinois, United States
Site 133
Beaufort, South Carolina, United States
Site 127
Ladson, South Carolina, United States
Site 122
Arlington, Texas, United States
Site 130
Bellaire, Texas, United States
Site 126
Harlingen, Texas, United States
Site 134
Houston, Texas, United States
Site 129
Katy, Texas, United States
Site 128
San Antonio, Texas, United States
Site 125
Salt Lake City, Utah, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AKST4290-231
Identifier Type: -
Identifier Source: org_study_id
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