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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
BD111 Injection (investigational new drug)
GeneticBD111: intrastromally injection, single-dosing 10E6 TU/eye, specified injection volume is 0.15mL.
Triple-drugs therapy of HSV-1 stromal keratitis
Combination productTriple-drugs therapy: "Ganciclovir Eye gel+Valacilovir Tablets+Prednisolone Acetate Eye Drops" for 3 weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Group 1Experimental treatment 2 interventions
Group B: Group 2Active comparator 1 intervention
Trial outcomes
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.
Time frame
12 monthsSecondary outcomes
1
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
The definition of successful HSV-1 clearance: negative results in tear swab HSV-1 nucleic acid tests on two consecutive samplings (interval ≥14 days). The definition of a negative result in tear swab HSV-1 nucleic acid test: single qPCR Ct value = 40 or "undetected", or Ct value of the first qPCR test "36 \< Ct value \< 40", and the Ct value of repetitive qPCR test is 40 or "undetected".
Time frame
12 months2
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
The failure of HSV-1 viral genome clearance is determinated by HSV-1 positive results of qPCR test. HSV-1 positive definition of qPCR test: qPCR Ct value ≤ 36, or qPCR Ct value is "36 \< Ct value \< 40" and the Ct value of repetitive qPCR test is ≤ 36, or results of both qPCR tests are "36 \< Ct value \< 40".
Time frame
12 months3
The percentage of participants with HSK recurrence at Day 180, and Day 365 post-administration
Definition of HSK recurrence: HSV-1 nucleic acid qPCR test is positive, and clinical symptoms presents again, and ophthalmic examinations find active inflammatory lesions on interventional eye.
Time frame
12 months4
Score change of corneal inflammation scale post-administration
From baseline to Day 70, Day 112, Day 180, and Day 365 post-administration.
Time frame
12 monthsSponsors and contacts
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Source ClinicalTrials.gov