Clinical Trial

Disease: Herpes Simplex Virus Refractory Keratitis, (NCT04560790)

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:
CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy Assisted Corneal Transplantation in the Treatment of Refractory Viral Keratitis
Who:

Contact

Principal Investigator: Yujia Cai, PhD, Shanghai BDgene Co., Ltd.

Locations:

China, Shanghai

Eye & Ent Hospital of Fudan University, Shanghai, Shanghai, China, 200000

Study start:
Nov. 4, 2020
Enrollment:
3 participants
Gene editing method:
CRISPR-Cas9
Type of edit:
Gene disruption
Gene:
UL8/UL29
Delivery method:
mRNA transfection - In-vivo
Safety updates:
IND Enabling Pre-clinical
Phase I Safety
Phase II Safety and Dosing
Phase III Safety and Efficacy

Status: Completed

Description

This is an open-label, single ascending dose study of BD111 in adult (ages 18 to 70) participants with refractory herpetic viral keratitis. Approximately 6 participants will be enrolled. BD111 is a novel gene editing product designed to clear Herpes simplex virus type I (HSV-1) that results in herpetic stromal keratitis in both acute and recurrent infection models which is the leading factor for infectious blindness.

Last updated: Jan. 11, 2025
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