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RECRUITING
NCT06474442
PHASE2

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

Sponsor: Shanghai BDgene Co., Ltd.

View on ClinicalTrials.gov

Summary

This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.

Official title: A Multicenter, Single-blind, Single-dose, Randomized, Phase Ⅱa Trial to Evaluate the Safety, Tolerability and Efficacy of Intrastromal BD111 Gene Editing Therapy in Adults With HSV-1 Stromal Keratitis

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2025-04-28

Completion Date

2027-03

Last Updated

2025-05-18

Healthy Volunteers

No

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.

Locations (1)

Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China