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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: f
View:

• BCVA of ≥ 24 and ≤ 73 letters (20/40 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)

• Diagnosis of diabetes mellitus, type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy. Any one of the following will be considered sufficient evidence that diabetes is present:

• Current regular use of insulin for the treatment of diabetes

• Current regular use of oral hypoglycemic agents for the treatment of diabetes

• DME based on investigator's clinical evaluation and demonstrated on fundus photographs, fluorescein angiograms, and/or spectral domain-optical coherence tomography (SD-OCT)

• Mean foveal thickness of at least 325 µm by SD-OCT

• Ability and willingness to comply with the treatment and follow up procedures

• Ability to understand and sign the informed consent form

• Intraocular pressure of ≤ 21 mm Hg on 2 or fewer IOP lowering medications

Locations
United States
Kentucky
University of Kentucky
RECRUITING
Lexington
Contact Information
Primary
Connie Dampier, BSN, MPA
dampier@uky.edu
859-562-0750
Backup
Mary C Crutchfield, BA
mary.crutchfield@uky.edu
859-218-2642
Time Frame
Start Date: 2025-03-13
Estimated Completion Date: 2027-07
Participants
Target number of participants: 5
Treatments
Experimental: Subjects with DME
Patients will receive a regimen of 96 mg tablets of K9 to be taken twice a day for 24 weeks.
Sponsors
Collaborators: Inflammasome Therapeutics, Inc.
Leads: Michelle Abou-Jaoude

This content was sourced from clinicaltrials.gov