A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis

NCT06474442 | Recruiting Phase 2

• 1 other identifier: BD-HSK-111002-Ⅱa
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Herpes Simplex Virus Type I Stromal Keratitis

Keywords

Herpes Simplex Virus Type I; Stromal Keratitis

Outcome Measures

Primary Outcomes (1)

• Clinical cure rate of HSK at Day 70 and Day112 post-administration

  Definition of HSK clinical cure: disappearance of the subject's clinical symptoms, disappearance of active inflammatory lesions on ophthalmologic examinations, and successful clearance of the HSV-1 viral genome.

  12 months

Secondary Outcomes (13)

• The percentage of participants with successful clearance of HSV-1 viral genome in tears at Day 14, Day 28, Day 70, Day 112, Day 180, and Day 365 post-administration

  12 months

• The percentage of participants with failed clearance of HSV-1 viral genome in tears at Day 14, Day 28, Day 70, Day 112, Day 180, and Day 365 post-administration

  12 months

• The percentage of participants with HSK recurrence at Day 180, and Day 365 post-administration

  12 months

• Score change of corneal inflammation scale post-administration

  12 months

• The improvement in best corrected visual acuity (BCVA)

  12 months

Study Arms (2)

Group 1

EXPERIMENTAL

BD111 combining triple-drugs therapy Group.

Genetic: BD111 Injection (investigational new drug); Combination Product: Triple-drugs therapy of HSV-1 stromal keratitis

Group 2

ACTIVE COMPARATOR

BD111 sham injection combining triple-drugs therapy group.

Combination Product: Triple-drugs therapy of HSV-1 stromal keratitis

Interventions

BD111 Injection (investigational new drug) GENETIC

BD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.

Also known as: BD111 Lentivirus-like particles, also called HSV-1-erasing lentiviral particles (HELP)

Group 1

Triple-drugs therapy of HSV-1 stromal keratitis COMBINATION_PRODUCT

Triple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.

Also known as: Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 contraception for 12 months after administration;
• Participants voluntarily join the study, sign an informed consent form, have good compliance, and cooperate with follow-up visits.

You may not qualify if:

• 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;
• 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 disease;
• 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;

Sponsors & Collaborators

• Shanghai BDgene Co., Ltd.: lead

Study Sites (1)

Eye Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

MeSH Terms

Interventions

Drugs, Investigational

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations

Study Officials

• Fujun Li, M.D.

  Shanghai BDgene Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Chen Wei, M.D.

CONTACT

+86-13757728118; chenweimd@hotmail.com

Ma Huixiang, M.D.

CONTACT

+86-13777770073; mahuixiang2002@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 25, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: May 18, 2025

Record last verified: 2025-05

Locations

CN (1)