Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451172
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2024-05-28
Brief Title:
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
Sponsor:
Eye ENT Hospital of Fudan University
Organization:
Eye ENT Hospital of Fudan University
Study Overview
Official Title:
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASOTARI
Brief 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 31 days 71 days 142 days 302 days and 905 days after treatment
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 31 days 71 days 142 days 302 days and 905 days after treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Fudan Eye and ENT Hospital | OTHER | 202301V1 | None |