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Tests treatment safety and results for Herpes Simplex Virus Type I Stromal Keratitis
Official title A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
ClinicalTrials.gov ID: NCT06474442
What this study is testing
What is BD111 Injection (investigational new drug)?
BD111 Injection (investigational new drug) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for herpes simplex virus type i stromal keratitis.
Also referred to as BD111 Lentivirus-like particles, also called HSV-1-erasing lentiviral particles (HELP).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to compare the clinical efficacy and safety of BD111 injection in combination with standard therapy vs. standard therapy in herpes simplex virus type I stromal keratitis (HSK), providing preliminary confirmation of the clinical effectiveness of BD111 in combination with standard therapy.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants must meet all of the following to be enrolled in this study.
- Aged 18 to 70 years old;
- Clinically diagnosed with herpes simplex virus stromal keratitis;
- Tear swab HSV-1 nucleic acid test (qPCR method) positive;
- No use of systemic antiviral drugs or corticosteroids within 48 hours before enrollment;
You likely can't join if
- Patients with any of the following conditions cannot be enrolled in this study
- Active ocular infection caused by other pathogens in the target eye or the fellow eye within 30 days before enrollment, including but not limited to...
- Patients with bilateral viral keratitis
- Previous corneal transplant surgery in the study eye;
- A history of adverse reactions or allergies to corticosteroids and sodium fluorescein, allergies to therapeutic or diagnostic protein products...
- Absence of tear film and blinking function;
See the full eligibility criteria
- Participants must meet all of the following to be enrolled in this study.
- Aged 18 to 70 years old;
- Clinically diagnosed with herpes simplex virus stromal keratitis;
- Tear swab HSV-1 nucleic acid test (qPCR method) positive;
- No use of systemic antiviral drugs or corticosteroids within 48 hours before enrollment;
- No systemic immune eye diseases;
- Good eyelid structure and blinking function;
- Eye structure and function assessment showing potential for visual recovery;
- No retinal detachment, with generally normal visual function;
- No history of corneal trauma;
- Visual acuity in the fellow eye is better than 20/200;
- 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...
- Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up visits.
- Patients with any of the following conditions cannot be enrolled in this study
- Active ocular infection caused by other pathogens in the target eye or the fellow eye within 30 days before enrollment, including but not limited to blepharitis, infectious conjunctivitis, keratitis, scleritis, and...
- Patients with bilateral viral keratitis
- Previous corneal transplant surgery in the study eye;
- 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...
- Absence of tear film and blinking function;
- Severe dry eye disease;
- Malignant ocular surface tumor;
- Glaucoma;
- Patients with systemic autoimmune diseases;
- 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);
- 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).
- HIV infection;
- Pregnant and lactating women (pregnancy in this trial is defined as a positive urine pregnancy test);
- Participation in other drug or medical device clinical trials;
- Alcohol or drug abuse;
- Lack of compliance with the trial or the ability to sign an informed consent form;
- Other situations deemed unsuitable for participation in the trial by the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wenzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wenzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.