A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
NCT ID: NCT06474442
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
40 participants
INTERVENTIONAL
2025-04-28
2027-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Group 1
BD111 combining triple-drugs therapy Group.
BD111 Injection (investigational new drug)
BD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.
Triple-drugs therapy of HSV-1 stromal keratitis
Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.
Group 2
BD111 sham injection combining triple-drugs therapy group.
Triple-drugs therapy of HSV-1 stromal keratitis
Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.
Interventions
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BD111 Injection (investigational new drug)
BD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.
Triple-drugs therapy of HSV-1 stromal keratitis
Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Clinically diagnosed with herpes simplex virus stromal keratitis;
3. Tear swab HSV-1 nucleic acid test (qPCR method) positive;
4. No use of systemic antiviral drugs or corticosteroids within 48 hours before enrollment;
5. No systemic immune eye diseases;
6. Good eyelid structure and blinking function;
7. Eye structure and function assessment showing potential for visual recovery;
8. No retinal detachment, with generally normal visual function;
9. No history of corneal trauma;
10. Visual acuity in the fellow eye is better than 20/200;
11. Fertile males or females must use highly effective contraceptive methods (such as oral contraceptives, intrauterine devices, abstinence, or barrier contraception combined with spermicides) during the trial and continue contraception for 12 months after administration;
12. Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up visits.
Exclusion Criteria
2. Patients with bilateral viral keratitis
3. Previous corneal transplant surgery in the study eye;
4. A history of adverse reactions or allergies to corticosteroids and sodium fluorescein, allergies to therapeutic or diagnostic protein products, allergies to ≥ two drugs or non-drug factors, or having an ongoing allergic disease;
5. Absence of tear film and blinking function;
6. Severe dry eye disease;
7. Malignant ocular surface tumor;
8. Glaucoma;
9. Patients with systemic autoimmune diseases;
10. Signs of systemic infection before enrollment, including fever and receiving antibiotic treatment (abnormal elevating values in white blood cells, lymphocytes, and neutrophils in routine blood tests);
11. Abnormal major organ function or other uncontrolled clinical problems, mainly including but not limited to the following:
* Severe kidney disease history, serum creatinine ≥ 133μmol/L;
* Liver dysfunction, transaminase level ≥ 80 IU/L;
* Uncontrolled hypertension, systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg;
* Uncontrolled diabetes, fasting blood glucose greater than or equal to 8.0 μmol/L;
* Cardiovascular disease history, with arrhythmia, myocardial ischemia, and myocardial infarction (diagnosed by electrocardiogram examination);
* Platelet level ≤ 100×10\^9/μL or ≥ 450×10\^9/μL due to any cause, hemoglobin level lower than 10.0g/dL (male) or 9.0g/dL (female).
12. HIV infection;
13. Pregnant and lactating women (pregnancy in this trial is defined as a positive urine pregnancy test);
14. Participation in other drug or medical device clinical trials;
15. Alcohol or drug abuse;
16. Lack of compliance with the trial or the ability to sign an informed consent form;
17. Other situations deemed unsuitable for participation in the trial by the investigator.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai BDgene Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Fujun Li, M.D.
Role: STUDY_DIRECTOR
Shanghai BDgene Co., Ltd.
Locations
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Eye Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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BD-HSK-111002-Ⅱa
Identifier Type: -
Identifier Source: org_study_id
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