Actively Recruiting
Kamuvudine-9 (K9) in Diabetic Macular Edema
Led by Dr. Bryan Strelow · Updated on 2026-03-10
10
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The objectives of this investigation are to assess: 1. whether oral K9 is safe in subjects with DME, and 2. whether oral K9 improves BCVA compared to oral placebo
CONDITIONS
Official Title
Kamuvudine-9 (K9) in Diabetic Macular Edema
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 years or older
- Diagnosis of diabetes mellitus type 1 or 2 with non-proliferative or non-high risk proliferative diabetic retinopathy
- Current regular use of insulin or oral hypoglycemic agents for diabetes treatment
- Diabetic macular edema confirmed by clinical evaluation and imaging (fundus photos, fluorescein angiograms, or SD-OCT)
- HbA1c of 12% or less at screening
- Best-corrected visual acuity (BCVA) between 24 and 68 letters on ETDRS chart in the study eye; non-study eye BCVA no worse than 20/400 Snellen equivalent
- Mean central subfield thickness (CST) of at least 325 micrometers by SD-OCT
- Intraocular pressure of 21 mm Hg or less on two or fewer IOP lowering medications
- Able to provide informed consent and willing to follow study protocol
- Females of childbearing potential and males must agree to abstain from sex or use contraception during the study and for 28 days after last dose
You will not qualify if you...
- Body weight less than 55 kg
- Macular edema from causes other than diabetes
- Proliferative diabetic retinopathy or iris neovascularization in the study eye
- Unable to follow study protocol
- Pregnant or breastfeeding females
- Panretinal or scatter laser photocoagulation within 12 months before screening
- Use of topical steroid or NSAIDs in study eye or oral NSAIDs within 30 days before screening
- Active or recent intraocular inflammation within 1 year
- Prior intraocular or periocular treatment for DME within specified timeframes (anti-VEGF within 6 weeks, steroid therapies within 12 months or 3 years, macular laser within 6 months)
- Aphakia or absence of posterior capsule in study eye
- YAG laser capsulotomy in study eye within 2 months before screening
- Change in systemic steroid therapy within 3 months before screening
- Ocular surgery in study eye within 12 weeks before screening
- Severe foveal ischemia in study eye
- Retinal or choroidal neovascularization from other ocular conditions
- History of viral or fungal eye infections or infectious retinitis in study eye
- Other diseases affecting study assessments or safety
- Lens or corneal opacity impairing retina visualization
- Allergy to study medication components
- Use of medications containing nucleotide reverse transcriptase inhibitors
- History of medications with retinal toxicity
- Clinically significant unstable medical conditions or lab abnormalities
- Active cancer or recent cancer history except certain treated skin or carcinoma in situ
- Recent use of other investigational drugs
- Participation in other clinical trials within 12 weeks
- Plans to move away from study site within 2 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Vistar Eye Center
Roanoke, Virginia, United States, 24019
Actively Recruiting
Research Team
M
Mary Galyen, BS, COA
CONTACT
B
Bryan Strelow, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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