Phase 2 Trial of Single-Dose BD111 Gene Editing Therapy with Standard Treatment for Adults Aged 18 to 70 With HSV-1 Stromal Keratitis

What this Trial Is About

Researchers are studying adults aged 18 to 70 years with herpes simplex virus type I stromal keratitis HSK to compare the safety and effectiveness of BD111 injection combined with standard therapy against standard therapy alone. This phase 1a, randomized, single-blind clinical trial aims to provide early evidence on how well BD111 works and how safe it is for treating HSK. BD111 is an investigational gene editing therapy designed to target the HSV-1 virus in the eye. The study involves two groups one receiving a single intrastromal injection of BD111 plus triple-drug therapy Ganciclovir eye gel, Valaciclovir tablets, and Prednisolone acetate eye drops for 3 weeks, and the other receiving a sham injection plus the same triple-drug therapy. The BD111 dose is 106 TU per eye in a 0.15 mL volume. Participants will be followed for 12 months to monitor safety and treatment effects. During the study, participants will undergo assessments including clinical cure rates at days 70 and 112, viral genome clearance in tears at multiple time points up to one year, recurrence monitoring, corneal inflammation scoring, and vision tests. Blood tests will check for antibodies and vector presence. Safety will be tracked through adverse event reporting. The total participation period is 12 months, with regular monitoring and evaluations throughout.

A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis