Actively Recruiting
CRISPR/Cas9 Instantaneous Gene Editing Therapy to Intraocular Hypertensive POAG With MYOC Mutation
Led by Shanghai BDgene Co., Ltd. · Updated on 2024-06-24
9
Participants Needed
1
Research Sites
77 weeks
Total Duration
On this page
Sponsors
S
Shanghai BDgene Co., Ltd.
Lead Sponsor
B
Beijing Tongren Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CRISPR/Cas9 Instantaneous Gene Editing Therapy to Intraocular Hypertensive POAG With MYOC Mutation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Aged 18 to 65 years old
- Diagnosed with primary open-angle glaucoma with elevated intraocular pressure for at least 1 year
- Good organ function
- Willing and able to comply with visit schedules, laboratory tests, and other protocol requirements
- Agree to long-term safety follow-up after 1 year of study
- For Group 1: Treated eye has no visual acuity; intraocular pressure between 21 and 35 mmHg despite treatment with two or more drugs
- For Group 2: Confirmed MYOC gene mutation; intraocular pressure between 21 and 30 mmHg despite treatment with two or more drugs; both eyes have Shaffer Angle mirror rating greater than 3
You will not qualify if you...
- Secondary glaucoma
- Active or recurring intraocular infection or inflammation including uveitis
- Severe dry eye or significant active corneal disease in treated eye
- Conditions preventing intraocular pressure measurement
- Positive for HIV-1/2, treponema pallidum, HTLV-1/2, or VSV-G antibodies
- Positive tests for hepatitis B, hepatitis C, Epstein-Barr virus, or cytomegalovirus
- Severe active systemic infections (bacterial, viral, fungal, malaria, parasitic)
- Past or present cancer, myeloproliferative or immunodeficient diseases
- History of major organ diseases or abnormal lab tests including liver cirrhosis, cardiovascular or cerebrovascular diseases, kidney disease, endocrine disorders, severe pulmonary conditions
- Severe psychiatric disorders
- Participation in another drug or device study or use of investigational drug within 42 days prior to screening
- Pregnant or breastfeeding women
- Refusal to use contraception
- Allergy to investigational drugs or their components
- Other conditions judged unsuitable by investigator
- For Group 2: Retinal diseases such as unexplained quadrant blindness or macular degeneration; history of anterior chamber angle stenosis or congenital glaucoma; central corneal thickness less than 480 µm or more than 620 µm
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
Actively Recruiting
Research Team
F
Fujun Li, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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