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Evaluation of K9 in Subjects With Diabetic Macular Edema (DME) | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

NCT06781255•Michelle Abou-Jaoude

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.

Eligibility

Age

18 - 89 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•Pregnant patients, currently lactating patients, or females of childbearing potential (unless using reliable contraception such as double barrier, surgical sterilization, oral contraceptives, intrauterine device (IUD), etc.
•Body weight less than 55 kg
•Allergy or hypersensitivity (known or suspected) to fluorescein or any component of the investigational product or delivery system
•Any ocular surgery in the study eye within 12 weeks of screening
•History of vitrectomy in the study eye
•Aphakia in the study eye
•Presence of severe foveal ischemia, defined as foveal avascular zone (FAZ) of \>1.5 mm2 on OCT-Angiography
•Prior intraocular or periocular treatment for DME including any of the following:
•Intravitreous injection of anti-VEGF therapies including but not limited to bevacizumab, ranibizumab, aflibercept, faricimab, and/or brolucizumab within the last 1 month
•Intravitreous or sub-Tenon delivery of any steroid therapy (such as triamcinolone, dexamethasone) in the last 6 months or a fluocinolone acetonide implant for 3 years.
+12 more criteria

Locations (1)

University of Kentucky

Lexington, Kentucky, United States

Key Dates

Start Date

March 13, 2025

Primary Completion Date

December 30, 2026

Completion Date

July 1, 2027

Last Updated

August 20, 2025

Enrollment

ESTIMATED participants

Conditions

Diabetic Macular Edema

Interventions

Kamuvudine-9

DRUG

Contacts

Connie Dampier, BSN, MPA

CONTACT

859-562-0750 dampier@uky.edu

Mary C Crutchfield, BA

CONTACT

859-218-2642 mary.crutchfield@uky.edu

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

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RECRUITINGPHASE3

CAPRI: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME

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