A Phase Ⅱa Study of the Safety, Tolerability and Efficacy of BD111 in Herpes Simplex Virus Type I Stromal Keratitis
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorShanghai BDgene Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- BD111 Injection (investigational new drug)
- Triple-drugs therapy of HSV-1 stromal keratitis
Treatment groups
40 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov