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

Alkahest

Status and phase: Terminated; Phase 2

Conditions: Diabetic Retinopathy

Treatments: Drug: AKST4290; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05038020

AKST4290-231

Details and patient eligibility

About

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

Full 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

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

AKST4290

Experimental group

Description:

Subjects will receive AKST4290, 400mg twice daily, for 24 weeks

Treatment:

Drug: AKST4290

Placebo

Placebo Comparator group

Description:

Subjects will receive matching Placebo, twice daily, for 24 weeks

Treatment:

Drug: Placebo