Actively Recruiting
A Phase 1a Trial to Evaluate the Safety, Tolerability, and Efficacy of Intrastromal BD111 Gene Editing Therapy in Adults with HSV-1 Stromal Keratitis
Led by Shanghai BDgene Co., Ltd. · Updated on 2025-05-18
40
Participants Needed
1
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adults aged 18 to 70 years with herpes simplex virus type I stromal keratitis (HSK) to compare the safety and effectiveness of BD111 injection combined with standard therapy against standard therapy alone. This phase 1a, randomized, single-blind clinical trial aims to provide early evidence on how well BD111 works and how safe it is for treating HSK. BD111 is an investigational gene editing therapy designed to target the HSV-1 virus in the eye. The study involves two groups: one receiving a single intrastromal injection of BD111 plus triple-drug therapy (Ganciclovir eye gel, Valaciclovir tablets, and Prednisolone acetate eye drops) for 3 weeks, and the other receiving a sham injection plus the same triple-drug therapy. The BD111 dose is 10^6 TU per eye in a 0.15 mL volume. Participants will be followed for 12 months to monitor safety and treatment effects. During the study, participants will undergo assessments including clinical cure rates at days 70 and 112, viral genome clearance in tears at multiple time points up to one year, recurrence monitoring, corneal inflammation scoring, and vision tests. Blood tests will check for antibodies and vector presence. Safety will be tracked through adverse event reporting. The total participation period is 12 months, with regular monitoring and evaluations throughout.
CONDITIONS
Brief Title
A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years old
- Clinically diagnosed with herpes simplex virus stromal keratitis
- Positive tear swab HSV-1 nucleic acid test (qPCR method)
- No systemic antiviral drugs or corticosteroids used within 48 hours before enrollment
- No systemic immune eye diseases
- Good eyelid structure and blinking function
- Eye assessment indicates potential for visual recovery
- No retinal detachment, with generally normal visual function
- No history of corneal trauma
- Visual acuity in the fellow eye better than 20/200
- Fertile males or females must use highly effective contraception during the trial and for 12 months after
- Voluntary participation with signed informed consent and compliance with follow-up visits
You will not qualify if you...
- Active ocular infection caused by other pathogens within 30 days before enrollment
- Bilateral viral keratitis
- Previous corneal transplant surgery in the study eye
- History of allergies to corticosteroids, diagnostic proteins, or multiple drugs
- Absence of tear film and blinking function
- Severe dry eye disease
- Malignant ocular surface tumor
- Glaucoma
- Systemic autoimmune diseases
- Signs of systemic infection before enrollment
- Abnormal major organ function or uncontrolled clinical problems such as severe kidney disease, liver dysfunction, uncontrolled hypertension or diabetes, cardiovascular disease, abnormal blood counts
- HIV infection
- Pregnancy or lactation
- Participation in other drug or device clinical trials
- Alcohol or drug abuse
- Lack of compliance or inability to provide informed consent
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 weeks
Participants receive a single intrastromal injection of BD111 combined with triple-drugs therapy or a sham injection combined with triple-drugs therapy for herpes simplex virus type I stromal keratitis.
1 baseline visit and weekly visits for 3 weeks
Duration - Up to 12 months
Participants are monitored for safety, tolerability, and efficacy outcomes including clinical cure rate, viral clearance, recurrence, visual acuity, and antibody response.
Multiple follow-up visits over 12 months, including assessments at Day 14, 28, 70, 112, 180, and 365 post-administration
Trial Site Locations
Total: 1 location
1
Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Actively Recruiting
Research Team
C
Chen Wei, M.D.
M
Ma Huixiang, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Frequently Asked Questions
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