Safety and Efficacy of CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy to Treat Refractory Vi… (NCT04560790) | Clinical Trial Compass
CompletedNot Applicable
Safety and Efficacy of CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy to Treat Refractory Viral Keratitis
China3 participantsStarted 2020-11-04
Plain-language summary
The purpose of this study is to evaluate the safety, tolerability and efficacy of a single escalating doses of BD111 CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy administered via corneal injection in participants with refractory herpetic viral keratitis.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Age between 18 to 70 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.
✓. Patients with refractory keratitis who are repeatedly infected with HSV-1 virus (more than three times per year) and resistant to topical or systemic anti-viral agents, with no response to regular immunosuppressive agents.
✓. Patients who are obviously suffering from relapse HSV infections with corneal perforation, requiring corneal transplantation;
✓. No history of corneal trauma.
✓. 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.
✕
What they're measuring
1
Effective clearance of HSV-1 genome
Timeframe: 12 months
2
Rate of reblindness in 3 participants with Refractory HSV Keratitis
Timeframe: 12 months
3
HSV-1 virus testing outcome of the intervention eye
. Active eye infection (including but not limited to: blepharitis, infectious conjunctivitis, keratitis, 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.