Clinical Trial

Disease: Herpes Simplex Virus Type I Stromal Keratitis, (NCT06474416)

Disease info:

Herpes simplex virus (HSV) keratitis is a viral infection of the cornea caused by HSV, primarily HSV type I. It often stems from reactivation of an earlier HSV infection, commonly affecting the mouth or face. Keratitis refers to corneal infections that result in corneal ulcers, open sores in the outer layer of the cornea. Keratitis may be categorised as acanthamoeba keratitis, fungal keratitis or herpes simplex keratitis. While most cases heal without lasting damage, severe infections can cause corneal scarring, vision loss, or blindness, making HSV keratitis a leading global cause of blindness.

Symptoms of keratitis include eye pain, redness, blurred vision, sensitivity to light, excessive tearing, and a feeling of something in the eye. Other signs may include eyelids that do not close fully (such as in Bell’s palsy), foreign bodies in the eye, scratches or abrasions on the corneal surface, severely dry eyes, severe allergic eye disease, and various inflammatory disorders.
 

Frequency:
Nearly 90% of people are exposed to HSV-1, often in childhood, although not all develop HSV keratitis. Recurrences are more likely in individuals with previous infections, especially those wearing contact lenses or exposed to certain triggers.
Official title:
A Multicenter, Open-label, Single Dose, Phase Ⅰ Trial to Evaluate the Safety, Tolerability and Prelinminary Efficacy of BD111 in Patients With Herpes Simplex Virus Type I Stromal Keratitis in China
Who:

Contact

Name: Huixiang Ma, M.D.

Phone: +86-13777770073

Email: mahuixiang2002@163.com

Partners:
Locations:

China, Shanghai City

Huashan Hospital, Fudan University, Shanghai, Shanghai City, China, 200000


China, Zhejiang

The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang, China, 310009


Eye Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, China, 310009

Study start:
Sep. 4, 2023
Enrollment:
16 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Viral genome excision
Gene:
Viral genome (HSV-1)
Delivery method:
Lentivirus-like particle (VLP) - In-vivo
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Active recruiting

Description

This Phase I study is intended to evaluate the safety, tolerability, PK/PD profiles and preliminary efficacy via corneal intrastromal administration in patients with herpes simplex virus-1 stromal keratitis (HSK), with a dose exploration of four ascending doses of BD111 (investigative drug product).

Last updated: Jan. 11, 2025
close
Search CRISPR Medicine