Actively Recruiting
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
Led by Eye & ENT Hospital of Fudan University · Updated on 2024-06-11
20
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
E
Eye & ENT Hospital of Fudan University
Lead Sponsor
S
Soochow University
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have bacterial keratitis with confirmed multidrug-resistant bacterial infection not controlled by existing antibiotics.
- Age must be over 18 years.
- No systemic immune-related eye diseases.
- Participants must have good eyelid structure and blinking function.
- There must be potential for visual recovery based on ocular structure and function evaluation.
- Participants or their legal guardians must voluntarily consent, comply with study procedures, and agree to follow-up visits.
You will not qualify if you...
- Loss of lacrimal coating or blinking function.
- Severe dry eye disease with Schirmer's test result less than 2mm.
- Pregnant or lactating women (positive pregnancy test).
- Participation in other drug or medical device clinical trials currently.
- Active eye infections (such as blepharitis, infectious conjunctivitis, sclerotitis, endophthalmitis) in either eye within the past 30 days.
- Presence of ocular surface malignant tumors.
- History of allergies to sodium luciferin, protein products used in treatment or diagnosis, multiple drug or non-drug allergies, or current allergic disease.
- Presence of infectious diseases requiring systemic treatment.
- Systemic immune diseases.
- Uncontrolled clinical problems including severe mental, neurological, cardiovascular, respiratory diseases, or malignant tumors.
- Ineffective contraception.
- Uncontrolled hypertension with systolic ≥160 mmHg or diastolic ≥100 mmHg.
- Uncontrolled diabetes with fasting glucose ≥10.0 umol/L.
- Renal insufficiency with serum creatinine >133 umol/L.
- Heart rhythm disorders, ischemia, or myocardial infarction.
- Liver dysfunction with elevated liver enzymes above 80 IU/L.
- Platelet count outside 100,000 to 450,000 /uL.
- Low hemoglobin below 10.0 g/dL (male) or 9.0 g/dL (female).
- Abnormal blood clotting times.
- HIV infection.
- Lack of compliance or inability to consent.
- Signs of systemic infection including fever or abnormal blood counts.
- Use of glucocorticoids or other systemic immunosuppressants.
- Other conditions judged unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
Research Team
J
Jiaxu Hong, M.D., Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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