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

• Status: Recruiting
• Trial end date: 2022-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Alkahest, Inc.

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. 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.