NCT06474442View on ClinicalTrials.gov

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

PHASE2RecruitingINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

April 28, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

March 31, 2027

Conditions
Herpes Simplex Virus Type I Stromal Keratitis
Interventions
GENETIC

BD111 Injection (investigational new drug)

BD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.

COMBINATION_PRODUCT

Triple-drugs therapy of HSV-1 stromal keratitis

"Triple-drugs therapy: Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops for 3 weeks."

Trial Locations (1)

Unknown

RECRUITING

Eye Hospital of Wenzhou Medical University, Wenzhou

All Listed Sponsors
lead

Shanghai BDgene Co., Ltd.

INDUSTRY