Evaluation of K9 in Subjects With Diabetic Macular Edema (DME) (NCT06781255) | Clinical Trial Compass
TerminatedPhase 1
Evaluation of K9 in Subjects With Diabetic Macular Edema (DME)
Stopped: Low recruitment outcome
United States1 participantsStarted 2025-03-13
Plain-language summary
A non-randomized study evaluating the safety of an orally administered inflammasome inhibitor, K9, for the treatment of diabetic macular edema (DME).
Who can participate
Age range18 Years – 89 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
What they're measuring
1
Adverse Events
Timeframe: 28 weeks
2
Change from baseline in central subfield thickness (CST)
Timeframe: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24
3
Mean change from baseline in best corrected visual acuity (BCVA)
Timeframe: Screening (baseline), Day 1 Visit, and weeks 6, 12, 18, and 24