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).
|Condition or Disease||Intervention/Treatment||Phase|
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
Arms and Interventions
Subjects will receive AKST4290, 400mg twice daily, for 24 weeks
|Placebo Comparator: Placebo|
Subjects will receive matching Placebo, twice daily, for 24 weeks
Primary Outcome Measures
- To investigate the efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline. [Baseline to Week 24]
Secondary Outcome Measures
- To investigate additional measures of efficacy of AKST4290 assessed by the improvement in the DRSS score from baseline. [Baseline to Week 24 or 28]
- To assess the proportion of participants progressing to (or worsening of) CI-DME, PDR, and/or anterior-segment neovascularization (ASNV). [Baseline to Week 28]
- To assess the time to event of CI-DME, PDR, and/or ASNV requiring treatment. [Baseline to Week 28]
- To assess the overall safety of AKST4290 assessed by the incidence and intenisty of adverse events. [Baseline to Week 28]
- 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]
- 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]
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).
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.
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.
Contacts and Locations
|1||Site 132||Phoenix||Arizona||United States||85021|
|2||Site 136||Phoenix||Arizona||United States||85053|
|3||Site 123||Glendale||California||United States||91203|
|4||Site 121||Huntington Beach||California||United States||92647|
|5||Site 116||Clearwater||Florida||United States||33761|
|6||Site 117||Sarasota||Florida||United States||34239|
|7||Site 118||Winter Haven||Florida||United States||33880|
|8||Site 120||Oak Forest||Illinois||United States||60452|
|9||Site 133||Beaufort||South Carolina||United States||29902|
|10||Site 127||Ladson||South Carolina||United States||29456|
|11||Site 122||Arlington||Texas||United States||76012|
|12||Site 130||Bellaire||Texas||United States||77401|
|13||Site 126||Harlingen||Texas||United States||78550|
|14||Site 134||Houston||Texas||United States||77025|
|15||Site 129||Katy||Texas||United States||77494|
|16||Site 128||San Antonio||Texas||United States||78240|
|17||Site 125||Salt Lake City||Utah||United States||84107|
Sponsors and Collaborators
- Alkahest, Inc.
- Study Director: Alkahest Medical Monitor, Alkahest, Inc.
Study Documents (Full-Text)None provided.