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CRISPR/Cas9 Instantaneous Gene Editing Therapy to Intraocular Hypertensive POAG With MYOC Mutation

Primary Open Angle Glaucoma Clinical Trial

Official title:
A Clinical Study on CRISPR/Cas9 Instantaneous Gene Editing Therapy to Primary Open-angle Glaucoma With Elevated Intraocular Pressure and MYOC Gene Mutation

Clinical Trial Summary

This study will be intented to evaluate the safety and tolerability of CRISPR/Cas9 Instantaneous Gene Editing Therapy (BD113 virus-like particle, also BD113vLVP) in patients with primary open-angle glaucoma (POAG) with elevated intraocular pressure and MYOC gene mutation. The main objectives to evaluate the safety and tolerability BD113vLVP) in POAG patients with intraocular hypertension and MYOC mutation, and secondary objectives is to explore the preliminary efficacy and the preliminary metabolism characteristics of BD113vLVP in participants.

Clinical Trial Description

This is an open, single-dose, single-arm, single-center clinical study. A total of 6 to 9 patients with primary open Angle glaucoma (POAG) with high intraocular pressure were enrolled and divided into two test groups. Test Group 1 recruits 3 patients with positive or negative MYOC gene mutation POAG and target interventing eye is no vision (absolute stage), and test Group 2 recruit 3 to 6 patients with MYOC mutations and visual POAG. In order to better verify the lowering IOP effectiveness of BD113vVLP, another 2 or 3 participants will be recruied in Group 2 on-demand. Each participant will receive one dosing BD113vVLP (4µg p24) by intracameral injection in the target eye, then undertakes the safety and efficacy evaluations according to visit planning in 1 year follow-up。 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06465537
Study type Interventional
Source Shanghai BDgene Co., Ltd.
Contact Fujun Li, M.D.
Phone 086-191 2131 1061
Email fujun.li@bdgene.cn
Status Recruiting
Phase N/A
Start date June 10, 2024
Completion date December 2025
View Details
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