AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingEARLY Phase 1Ages 18 Years - anyAllEye & ENT Hospital of Fudan University
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: * 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 โ‰ฅ 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
๐Ÿ’Š

What it tests

  • ASO
๐Ÿ“

Where

1 site
Eye & ENT Hospital of Fudan University
Shanghai, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy