Kamuvudine-9 for Diabetic Macular Edema

Overseen By Mary C Crutchfield, BA

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Michelle Abou-Jaoude

Must be taking: Insulin, Oral hypoglycemics

Must not be taking: Anti-VEGF, Steroids

Disqualifiers: Pregnancy, Recent ocular surgery, Severe foveal ischemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 4 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Michelle Abou-Jaoude, MD

Principal Investigator

University of Kentucky

Eligibility Criteria

This trial is for individuals with Diabetic Macular Edema (DME), a condition where fluid accumulates in the retina due to diabetes, causing swelling and vision problems. Specific eligibility criteria are not provided.

Inclusion Criteria

BCVA of ≥ 24 and ≤ 68 letters (20/50 or worse but at least 20/320) by an ETDRS chart. BCVA of the non-study eye must be no worse than 20/400 Snellen equivalent

I have diabetes with a specific eye condition but not severe retinopathy.

Ability to understand and sign the informed consent form

Exclusion Criteria

I have had eye infections or diseases caused by viruses, bacteria, or fungi.

I haven't had eye surgery in the last 12 weeks.

I have had eye treatments for DME within the allowed time.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive 96 mg tablets of K9 twice a day for 4 weeks

4 weeks

Weekly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Kamuvudine-9

Trial Overview The study is testing K9, an orally taken medication that aims to reduce inflammation in the eye. It's a non-randomized trial, meaning all participants will receive K9 without being compared to a placebo or other treatment.

Participant Groups

Group I: Subjects with DME Experimental Treatment 1 Intervention

Participants receive a regimen of 96 mg tablets of K9 twice a day for 4 weeks

Who Is Running the Clinical Trial?

Michelle Abou-Jaoude

Lead Sponsor

Trials

2

Recruited

6+

Inflammasome Therapeutics, Inc.

Collaborator

Trials

1

Recruited

5+