NCT06781255

Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Michelle Abou-Jaoude · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).

Detailed description

This is an twenty-eight (28) week non-randomized, open-label, safety study evaluating twice daily, oral K9 in five (5) patients. Subjects with DME meeting inclusion/exclusion criteria will be offered enrollment into this study. A screening visit and subject selection criteria will be used to assess subject eligibility prior to enrollment. Patients will be supplied with tablets of K9 to be taken orally BID for 24 weeks. Safety will be assessed over a series of visits over an 28 week period.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	Kamuvudine-9	96 mg tablets taken twice a day for 24 weeks

Timeline

• Start date: 2025-03-13
• Primary completion: 2026-02-25
• Completion: 2026-02-25
• First posted: 2025-01-17
• Last updated: 2026-04-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study