Early Phase 1 Study of Novel Antisense Oligonucleotide Eye Drops for Treating Severe Antibiotic-Resistant Bacterial Keratitis in Adults

What this Trial Is About

Researchers are evaluating the safety and effectiveness of GP-asPNA, a novel antisense oligonucleotide therapy, for treating severe antibiotic-resistant bacterial keratitis in adults aged 18 to 70. This condition, often caused by trauma or eye surgery, is a leading cause of vision loss due to infection, particularly in developing countries. The study focuses on targeting multidrug-resistant bacteria that current antibiotics cannot control. The treatment involves ASO eye drops administered directly to the affected eye. Participants will use a 20 microliter dose, applied three times daily. The study enrolls approximately 20 participants in a single-group design. Follow-up visits to monitor treatment effects and safety occur at 1, 3, 7, 14, 30, and 90 days after treatment. Participants will undergo bacteria testing and assessments of eye health and vision improvement throughout the 90-day follow-up. Researchers will measure bacterial presence and therapeutic effects of the eye drops, as well as changes in vision compared to baseline. The study includes careful monitoring to track safety and treatment response over time.

Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis