Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
NCT ID: NCT06451172
Last Updated: 2024-06-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
20 participants
INTERVENTIONAL
2023-10-11
2026-10-31
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ASO Single Group
ASO eye drops are used through the local administration. Dosage form: eye drop solution. Dose:20uL. Frequency of administration: 3 times per day.
ASO
Anticipated 20 Participants will receive a single group administered via eye drops in the study eye.
Interventions
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ASO
Anticipated 20 Participants will receive a single group administered via eye drops in the study eye.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
* Liver dysfunction, al ANINE aminotransferase and aspartate aminotransferase levels are higher than 80 IU/L.
* Platelet level is below 100,000 /uL or above 450,000 /uL.
* Hemoglobin level is below 10.0g/dL (male) or 9.0g/dL (female).
* No anticoagulant was used, prothrombin time is higher than 16s, and thrombin time of activated part is higher than 50s.
* HIV infection (HIV-positive).
* Subjects lack compliance with the study or the ability to sign informed consent.
* There are currently signs of systemic infection, including fever and ongoing antibiotic treatment (in this study, systemic infection was defined as deviation from normal values of white blood cells, lymphocytes, and neutrophils on routine blood tests).
* Administration of Glucocorticoids and other systemic immunosuppressive drugs.
* The investigator judges other conditions unsuitable for the trial
18 Years
ALL
No
Sponsors
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Soochow University
OTHER
Eye & ENT Hospital of Fudan University
OTHER
Responsible Party
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Principal Investigators
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Jiaxu Hong, M.D., Ph.D
Role: STUDY_DIRECTOR
Eye, and ENT Hospital,Shanghai Medical College, Fudan University,Shanghai, China
Locations
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Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Brown ED, Wright GD. Antibacterial drug discovery in the resistance era. Nature. 2016 Jan 21;529(7586):336-43. doi: 10.1038/nature17042.
Liu 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.
Zhang 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.
Other Identifiers
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Fudan Eye and ENT Hospital
Identifier Type: OTHER
Identifier Source: secondary_id
202301V1
Identifier Type: -
Identifier Source: org_study_id
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