Update on the Management of Infectious Keratitis.
Ariana Austin, Tom Lietman, Jennifer Rose-Nussbaumer
https://pubmed.ncbi.nlm.nih.gov/28942073Actively Recruiting
Early Phase 1
Age: 18Years +
All Genders
ID06451172
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
108 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
Researchers are evaluating the safety and effectiveness of GP-asPNA, a novel antisense oligonucleotide therapy, for treating severe antibiotic-resistant bacterial keratitis in adults aged 18 to 70. This condition, often caused by trauma or eye surgery, is a leading cause of vision loss due to infection, particularly in developing countries. The study focuses on targeting multidrug-resistant bacteria that current antibiotics cannot control. The treatment involves ASO eye drops administered directly to the affected eye. Participants will use a 20 microliter dose, applied three times daily. The study enrolls approximately 20 participants in a single-group design. Follow-up visits to monitor treatment effects and safety occur at 1, 3, 7, 14, 30, and 90 days after treatment. Participants will undergo bacteria testing and assessments of eye health and vision improvement throughout the 90-day follow-up. Researchers will measure bacterial presence and therapeutic effects of the eye drops, as well as changes in vision compared to baseline. The study includes careful monitoring to track safety and treatment response over time.
CONDITIONS
Brief Title
Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Results of antimicrobial susceptibility testing show multidrug-resistant bacterial infection in bacterial keratitis.
- Existing commercial antibiotics are ineffective in controlling the disease.
- Age over 18 years.
- No systemic immune eye disease.
- Good eyelid structure and blink function.
- Potential for visual recovery based on ocular structure and function evaluation.
- Voluntary participation with signed informed consent and good compliance for follow-up visits.
You will not qualify if you...
- Loss of lacrimal coating and blink function.
- Severe dry eye disease with Schirmer's test less than 2mm.
- Pregnant or lactating women.
- Currently involved in other clinical trials of drugs or medical devices.
- Active eye infection in either eye within 30 days prior to enrollment.
- Ocular surface malignant tumor.
- History of allergic reactions to sodium luciferin, protein treatment products, multiple drugs, or current allergic disease.
- Infectious disease requiring oral, intramuscular, or intravenous treatment.
- Systemic immune diseases.
- Uncontrolled severe mental, neurological, cardiovascular, respiratory diseases, or malignant tumors.
- Ineffective contraception.
- Uncontrolled hypertension (systolic ≥160 mmHg or diastolic ≥100 mmHg).
- Uncontrolled diabetes (fasting glucose ≥10.0 umol/L).
- Renal insufficiency (serum creatinine >133 umol/L).
- Arrhythmia, myocardial ischemia, or myocardial infarction diagnosed by ECG.
- Liver dysfunction with elevated liver enzymes (>80 IU/L).
- Platelet count below 100,000/uL or above 450,000/uL.
- Low hemoglobin (<10.0 g/dL for males or <9.0 g/dL for females).
- Abnormal coagulation times.
- HIV infection.
- Lack of compliance or inability to consent.
- Signs of systemic infection including fever or ongoing antibiotic treatment.
- Use of glucocorticoids or systemic immunosuppressive drugs.
- Other conditions judged unsuitable by the investigator.
AI-Screening
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Complete this quick 3-step screening to check your eligibility
1
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Treatment
Duration - Duration of treatment not explicitly stated
Participants receive antisense oligonucleotide (ASO) eye drops administered locally to the study eye three times per day.
1 baseline visit and 6 follow-up visits over 90 days
Trial Site Locations
Total: 1 location
1
Eye & ENT Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
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Research Team
J
Jiaxu Hong, M.D., Ph.D
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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Mingzhu Liu, Binbin Chu, Rong Sun...
https://pubmed.ncbi.nlm.nih.gov/37002615In vivo bioluminescence imaging of natural bacteria within deep tissues via ATP-binding cassette sugar transporter.
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https://pubmed.ncbi.nlm.nih.gov/37087540