Randomized Trial of Kamuvudine-9 (K9) in DME

NCT07458061 Phase 1/Phase 2 RECRUITING

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

Details

Lead sponsor	Dr. Bryan Strelow
Phase	Phase 1/Phase 2
Status	RECRUITING
Enrolment	10
Start date	2026-02
Completion	2026-08

Conditions

• Diabetic Macular Edema

Interventions

• Placebo Tablet: BID
• Kamuvudine K9

Primary outcomes

• Number of participants with treatment-related adverse events as assessed by CTCAE v6.0 — 4 weeks
  Number of participants with treatment-related adverse events as assessed by CTCAE v6.0.
• Change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart — 4 weeks
  To evaluate the effects of K9 based on change from baseline Best-Corrected Visual Acuity measured using the standardized ETDRS chart

Countries

United States