Trials / Recruiting
RecruitingNCT06451172
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
- Status
- Recruiting
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 20 (estimated)
- Sponsor
- Eye & ENT Hospital of Fudan University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the safety and efficacy of GP-asPNA for in vivo treatment of severe antibiotic resistant bacterial keratitis.
Detailed description
This is a study of antisense oligonucleotides (ASOs) in adult (ages 18 to 70) participants with severe antibiotic resistant bacterial keratitis. Approximately 20 participants will be enrolled. Infectious keratitis or endophthalmitis, mainly caused by the trauma or intraocular surgical operation, has posed a grave threat to human vision health. Among them, infectious keratitis is the most common blinding keratopathy in developing countries. We develop a novel kind of Trojan strategy to specifically deliver ASOs into diverse bacteria rather than mammalian cells through the bacterial-specific ATP-binding cassette (ABC) sugar transporter. Compared with their cell-penetrating peptide counterparts, the antisense peptide nucleic acid modified with glucose polymer can be selectively internalized into human-derived multidrug- resistant Escherichia coli and methicillin-resistant Staphylococcus aureus, and they display a much higher uptake rate. The follow-up period was 90 days, and the patients will be followed up 1 days, 3±1 days, 7±1 days, 14±2 days, 30±2 days, and 90±5 days after treatment.
Conditions
- Bacterial Keratitis
- Antibiotic-resistant Bacteria
- Infections, Bacterial
- Corneal Diseases
- Eye Diseases
- Vision Disorders
- Sensation Disorders
- Blindness
- Antisense Peptide Nucleic Acid
- Antibacterial Therapy
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ASO | Anticipated 20 Participants will receive a single group administered via eye drops in the study eye. |
Timeline
- Start date
- 2023-10-11
- Primary completion
- 2024-10-01
- Completion
- 2026-10-31
- First posted
- 2024-06-11
- Last updated
- 2024-06-11
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06451172. Inclusion in this directory is not an endorsement.