Evaluating BD111 for treating herpes simplex virus type I stromal keratitis
A Multicenter, Single-blind, Single-dose, Randomized, Phase Ⅱa Trial to Evaluate the Safety, Tolerability and Efficacy of Intrastromal BD111 Gene Editing Therapy in Adults With HSV-1 Stromal Keratitis
This study is testing a new injection called BD111 to see if it can help people with herpes simplex virus type I eye infections feel better when used with standard treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai BDgene Co., Ltd. Industry-sponsored |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT06474442 on ClinicalTrials.gov |
What this trial studies
This phase Ⅱa clinical trial investigates the safety, tolerability, and efficacy of BD111 injection in combination with standard therapy for patients with herpes simplex virus type I stromal keratitis. The study will enroll 40 participants aged 18 to 70 years, who will receive a single dose of BD111 or standard therapy alone. BD111 is an investigational biologic designed to target and eliminate the HSV-1 virus. Participants will be followed for 12 months to assess the treatment's effectiveness and safety profile.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a confirmed diagnosis of herpes simplex virus stromal keratitis and positive HSV-1 nucleic acid test.
Not a fit: Patients with systemic immune eye diseases or those who have recently used systemic antiviral drugs or corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve outcomes for patients suffering from herpes simplex virus type I stromal keratitis.
How similar studies have performed: While this approach is novel, similar studies targeting viral infections with biologics have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Participants must meet all of the following inclusion criteria to be enrolled in this study.
1. Aged 18 to 70 years old;
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: Patients with any of the following conditions cannot be enrolled in this study
1. 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 endophthalmitis;
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.
Where this trial is running
Wenzhou, Zhejiang
- Eye Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Chen Wei, M.D.
- Email: chenweimd@hotmail.com
- Phone: +86-13757728118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.