RecruitingPhase 2NCT06474442

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

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

Sponsor

Shanghai BDgene Co., Ltd.

Enrollment

40 participants

Start Date

Apr 28, 2025

Study Type

INTERVENTIONAL

Conditions

Herpes Simplex Virus Type I Stromal Keratitis

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.

Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying BD111 Injection (investigational new drug) and Triple-drugs therapy of HSV-1 stromal keratitis for people with herpes simplex virus type i stromal keratitis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 70 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICBD111 Injection (investigational new drug)

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

COMBINATION_PRODUCTTriple-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

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NCT06474442