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

NCT06781255 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 100315
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema; Kamuvudine-9

Outcome Measures

Primary Outcomes (3)

• Adverse Events

  Frequency of participants experiencing ocular or systemic adverse events.

  28 weeks

• Change from baseline in central subfield thickness (CST)

  Central subfield thickness (CST) measured on spectral domain-optical coherence tomography (SD-OCT)

  Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24

• Mean change from baseline in best corrected visual acuity (BCVA)

  Mean change from baseline assessed by the ETDRS chart. Best-corrected visual acuity as defined by the number of letters read on the scale set by the ETDRS (Early Treatment of Diabetic Retinopathy Study). (More letters read equates to better visual acuity)

  Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24

Secondary Outcomes (4)

• Change from baseline in macular volume on spectral domain-optical coherence tomography (SD-OCT)

  Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24

• Change from baseline in retinal thickening on fundus photography

  Screening (baseline), and weeks 6, 12, 18, and 24

• Change from baseline in hard exudates in lesion involving the macula on fundus photography

  Screening (baseline), and weeks 6, 12, 18, and 24

• Change from baseline in foveal avascular zone on optical coherence tomography angiography (OCT-A)

  Screening (baseline), and weeks 6, 12, 18, and 24

Study Arms (1)

Subjects with DME

EXPERIMENTAL

Patients will receive a regimen of 96 mg tablets of K9 to be taken twice a day for 24 weeks.

Drug: Kamuvudine-9

Interventions

Kamuvudine-9 DRUG

96 mg tablets taken twice a day for 24 weeks

Subjects with DME

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Macular laser for the treatment of diabetic macular edema within 6 months of screening
• Any change in systemic steroidal therapy within 3 months of screening
• Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy (e.g. presumed ocular histoplasmosis, high myopia (spherical equivalent greater than 8 diopters), macular degeneration)
• History or presence of viral disease of the cornea or conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, varicella, any mycobacterial infections of the eye, or any fungal disease of any ocular structure or history of infectious retinitis
• History or presence of any disease or condition that in the investigator's opinion would preclude study treatment or follow-up or that in the opinion of the investigator would render them as unlikely to benefit from study treatment.

Sponsors & Collaborators

• Michelle Abou-Jaoude: lead
• Inflammasome Therapeutics: collaborator

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

RECRUITING

Study Officials

• Michelle Abou-Jaoude, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Connie Dampier, BSN, MPA

CONTACT

859-562-0750; dampier@uky.edu

Mary C Crutchfield, BA

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Unmasked
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)