Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
ASOTARI
2 other identifiers
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Oct 2023
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 11, 2023
CompletedFirst Submitted
Initial submission to the registry
May 28, 2024
CompletedFirst Posted
Study publicly available on registry
June 11, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2026
ExpectedJune 11, 2024
June 1, 2024
12 months
May 28, 2024
June 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bacteria testing outcome of the intervention eye
Assess the efficacy of bacteria clearance based on RNA sequencing data using techniques such as ELISA and PCR. For instance, real-time polymerase chain reaction (PCR) is utilized to identify 16S rRNA in corneal biopsy samples.
90 Days
Ophthalmic therapeutic effect of ASO eye drops
Measure the decrease in size, depth and infiltrate of the ulcer in millimeters by slit lamp biomicroscopy.
90 Days
Secondary Outcomes (1)
Visual improvement compared with baseline
90 Days
Study Arms (1)
ASO Single Group
EXPERIMENTALASO eye drops are used through the local administration. Dosage form: eye drop solution. Dose:20uL. Frequency of administration: 3 times per day.
Interventions
Anticipated 20 Participants will receive a single group administered via eye drops in the study eye.
Eligibility Criteria
You may qualify if:
- The results of antimicrobial susceptibility testing in patients with bacterial keratitis showed multidrug-resistant bacterial infections, and the existing commercial antibiotics could not effectively control the disease.
- Age over 18 years.
- No systemic immune eye disease.
- Good eyelid structure and blink function.
- Exists the potential of visual recovery by evaluation of ocular structure and function.
- Subjects or their legal guardians voluntarily participate in this study, sign informed consent, good compliance and cooperation with follow-up visits.
You may not qualify if:
- Lacrimal coating and blink function loss.
- Schirmer's test result is less than 2mm for severe dry eye disease.
- Pregnant and lactating women (pregnancy defined in this study as positive urine pregnancy test).
- Currently is involved in clinical trials of other drugs or medical devices.
- Active eye infection (including but not limited to: blepharitis, infectious conjunctivitis, sclerotitis, endophthalmitis) in target eye or contralateral eye within 30 days prior to enrollment.
- Ocular surface malignant tumor.
- A history of allergic reaction or allergy to sodium luciferin, allergy to protein products used for treatment or diagnosis, allergy to ≥ 2 drugs or non-drug factors, or current allergic disease.
- current in an infectious disease requiring oral, intramuscular or intravenous administration.
- Patients with systemic immune diseases.
- Any uncontrolled clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant neoplasms).
- Not effective contraception.
- In uncontrolled hypertension, systolic is no less than 160 mmhg, diastolic is no less than 100 mmhg.
- In uncontrolled diabetes, fasting glucose is no less than 10.0umol/L.
- Renal insufficiency, serum creatinine is more than 133umol/L.
- Arrhythmia, myocardial ischemia, myocardial infarction (diagnosed by electrocardiogram).
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eye & ENT Hospital of Fudan Universitylead
- Soochow Universitycollaborator
Study Sites (1)
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, 200031, China
Related Publications (4)
Austin A, Lietman T, Rose-Nussbaumer J. Update on the Management of Infectious Keratitis. Ophthalmology. 2017 Nov;124(11):1678-1689. doi: 10.1016/j.ophtha.2017.05.012. Epub 2017 Sep 21.
PMID: 28942073RESULTBrown ED, Wright GD. Antibacterial drug discovery in the resistance era. Nature. 2016 Jan 21;529(7586):336-43. doi: 10.1038/nature17042.
PMID: 26791724RESULTLiu M, Chu B, Sun R, Ding J, Ye H, Yang Y, Wu Y, Shi H, Song B, He Y, Wang H, Hong J. Antisense Oligonucleotides Selectively Enter Human-Derived Antibiotic-Resistant Bacteria through Bacterial-Specific ATP-Binding Cassette Sugar Transporter. Adv Mater. 2023 Jul;35(28):e2300477. doi: 10.1002/adma.202300477. Epub 2023 May 26.
PMID: 37002615RESULTZhang Q, Song B, Xu Y, Yang Y, Ji J, Cao W, Lu J, Ding J, Cao H, Chu B, Hong J, Wang H, He Y. In vivo bioluminescence imaging of natural bacteria within deep tissues via ATP-binding cassette sugar transporter. Nat Commun. 2023 Apr 22;14(1):2331. doi: 10.1038/s41467-023-37827-9.
PMID: 37087540RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jiaxu Hong, M.D., Ph.D
Eye, and ENT Hospital,Shanghai Medical College, Fudan University,Shanghai, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2024
First Posted
June 11, 2024
Study Start
October 11, 2023
Primary Completion
October 1, 2024
Study Completion (Estimated)
October 31, 2026
Last Updated
June 11, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share