About this trial
This study is intented to evaluate the safety, tolerability and preliminary efficacy 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 metabolism characteristics of BD113vLVP in participants.
Eligibility criteria
Qualifiers
Signed ICF;
Aged 18 to 65 years old;
Primary open Angle glaucoma (POAG) with elevated intraocular pressure (IOP) was diagnosed with ≥1 year medical history record ;
Good function level of organs;
Disqualifiers
Secondary glaucoma;
Any active or recurrent intraocular infection or inflammation, including but not limited to uveitis;
The target intervenning eye has severe xerophthalmia or clinically significant active corneal disease;
Any condition no accepting the measure of IOP;
Trial design
Treatments tested in this trial
- BD113vVLP
Treatment groups
Sponsors and collaborators
Shanghai BDgene Co., Ltd.
Lead sponsor
Beijing Tongren Hospital
Collaborator