Clinical Trial

Disease: Herpes Simplex Virus Refractory Keratitis, (NCT04560790)

Disease info:

Keratitis is an inflammation of the cornea, the clear, dome-shaped tissue on the front of your eye that covers the pupil and iris. Keratitis may or may not be associated with an infection. Non-infectious keratitis can be caused by a relatively minor injury, by wearing your contact lenses too long or by a foreign body in the eye. Infectious keratitis can be caused by bacteria, viruses, fungi and parasites.

HSV (Herpes Simplex Virus) keratitis is an infection of the cornea that is caused by HSV. The infection usually heals without damaging the eye, but more severe infections can lead to scarring of the cornea or blindness. HSV keratitis is a major cause of blindness worldwide. HSV-1, which is the type of HSV that also causes cold sores on the mouth, is the most common cause of corneal infections.

HSV is only found in humans and is spread through direct contact with someone who is infected with the virus. Most HSV keratitis infections happen after another part of the body, most commonly the mouth, has already been infected by HSV. HSV keratitis is often the result of a “flare up” (reactivation) of the earlier infection.



An estimated 3.7 billion people under age 50 (67%) have HSV-1 infection globally. An estimated 491 million people aged 15-49 (13%) worldwide have HSV-2 infection.
Official title:
CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy Assisted Corneal Transplantation in the Treatment of Refractory Viral Keratitis


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


China, Shanghai

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

Study start:
Nov. 4, 2020
3 participants
Gene editing method:
Type of edit:
Gene disruption
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


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: Apr. 20, 2024
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