NCT06451172 Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
| NCT ID | NCT06451172 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Eye & ENT Hospital of Fudan University |
| Condition | Bacterial Keratitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-10-11 |
| Primary Completion | 2024-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2023-10-11 with a primary completion date of 2024-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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 ≥ 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
Contact & Investigator
Jiaxu Hong, M.D., Ph.D
STUDY DIRECTOR
Eye, and ENT Hospital,Shanghai Medical College, Fudan University,Shanghai, China
Frequently Asked Questions
Who can join the NCT06451172 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bacterial Keratitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06451172 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06451172 currently recruiting?
Yes, NCT06451172 is actively recruiting participants. Contact the research team at chengmingruicmr@163.com for enrollment information.
Where is the NCT06451172 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06451172 clinical trial?
NCT06451172 is sponsored by Eye & ENT Hospital of Fudan University. The principal investigator is Jiaxu Hong, M.D., Ph.D at Eye, and ENT Hospital,Shanghai Medical College, Fudan University,Shanghai, China. The trial plans to enroll 20 participants.