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 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.
• 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.