Clinical Trial

Disease: Herpes Simplex Virus Type I Stromal Keratitis, (NCT06474442)

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, 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
Who:

Contact 

Name: Chen Wei, M.D.

Phone: +86-13757728118

Email: chenweimd@hotmail.com

Contact Backup

Name: Ma Huixiang, M.D.

Phone: +86-13777770073

Email: mahuixiang2002@163.com

Partners:
Locations:

China, Zhejiang

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

Study start:
Sep. 1, 2024
Enrollment:
40 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
Note:
This is the phase 2 study for trial #NCT06474416
Indicator
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Not yet recruiting

Description

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.

Last updated: Jan. 9, 2025
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