Clinical trial NCT05038020: A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Diabetic Retinopathy
Keywords: CCR3 inhibition
Diabetic Retinopathy
Oral Treatment
Lead sponsor: Alkahest, Inc.
Sponsor class: INDUSTRY
First posted: 2021-09-08
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Eligibility 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. 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.

Primary outcomes:
measure: To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
timeFrame: Baseline to Week 24
Secondary outcomes:
measure: To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.
timeFrame: Baseline to Week 24 or 28
measure: 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).
timeFrame: Baseline to Week 28
measure: To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.
timeFrame: Baseline to Week 28
measure: To Assess the Overall Safety of AKST429
timeFrame: Baseline to Week 28
measure: To Assess the Effect of AKST4290 on Diabetic Kidney Disease
timeFrame: Baseline to Week 28
measure: To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Site 132
state: Arizona
city: Phoenix
country: United States
facility: Site 136
state: Arizona
city: Glendale
country: United States
facility: Site 123
state: California
city: Huntington Beach
country: United States
facility: Site 121
state: California
city: Clearwater
country: United States
facility: Site 116
state: Florida
city: Sarasota
country: United States
facility: Site 117
state: Florida
city: Winter Haven
country: United States
facility: Site 118
state: Florida
city: Oak Forest
country: United States
facility: Site 120
state: Illinois
city: Beaufort
country: United States
facility: Site 133
state: South Carolina
city: Ladson
country: United States
facility: Site 127
state: South Carolina
city: Arlington
country: United States
facility: Site 122
state: Texas
city: Bellaire
country: United States
facility: Site 130
state: Texas
city: Harlingen
country: United States
facility: Site 126
state: Texas
city: Houston
country: United States
facility: Site 134
state: Texas
city: Katy
country: United States
facility: Site 129
state: Texas
city: San Antonio
country: United States
facility: Site 128
state: Texas
city: Salt Lake City
country: United States
facility: Site 125
state: Utah
Study officials:
affiliation: Alkahest, Inc.
name: Alkahest Medical Monitor
role: STUDY_DIRECTOR
References: