Kamuvudine-9 (K9) in Diabetic Macular Edema (NCT07458061)
Randomized Trial of Kamuvudine-9 (K9) in DME
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (13 items) and avoid the listed exclusions (30 items).
Location: Vistar Eye Center — Roanoke, Virginia
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Body weight \< 55 kg.
- Macular edema considered to be due to causes other than diabetes.
- Proliferative diabetic retinopathy or iris neovascularization (including the anterior chamber angle) in the study eye.
- Inability to follow the study protocol, based on the investigator's assessment.
- Females who are pregnant or breastfeeding.
- Panretinal or scatter laser photocoagulation within 12 months of screening.
- Topical steroid or topical NSAID in the study eye or oral NSAID treatment within 30 days of screening.
- Active ocular inflammation of any history of intraocular inflammation within 1 year.
- 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 6 weeks of screening Intravitreous or sub-Tenon delivery of steroid therapy (e.g. triamcinolone, dexamethasone) within 12 months or fluocinolone acetonide implant within 3 years of screening.
- Macular laser for the treatment of DME within 6 months of screening
- Aphakia or total absence of the posterior capsule in the study eye.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- Vistar Eye Center — Roanoke, Virginia
📞 Contact the Study Coordinator
Phone: (826) 867-8808
Email: mgalyen@vistareye.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Diabetic Macular Edema
- Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME) — Reno, Nevada
- A Study in People With Diabetic Macular Edema to Test How Well Different Doses of BI 3812465 Are Tolerated — Phoenix, Arizona
- Effect of Levosulpiride on Retinal Alterations in Patients With Diabetic Retinopathy and Diabetic Macular Edema — Querétaro City, Querétaro
- COMO: A Phase 3 Randomized, Double-Masked Study Comparing the Efficacy of EYP-1901 Against Aflibercept in DME — Bakersfield, California
- Long-Term Follow-up Study of ADVM-022 in DME (INFINITY-EXT) — Beverly Hills, California
- EC-104 Intravitreal Implant for the Treatment of Diabetic Macular Edema — Tampa, Florida
Explore by condition: All Diabetic Macular Edema clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.