Safety and Efficacy of CRISPR/Cas9 mRNA Instantaneous Gene Editing Therapy to Treat Refractory Viral Keratitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-04

Study Completion Date

2022-07-05

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Femtosecond Laser-assisted Corneal Debridement for Herpes Simplex Keratitis

NCT03217474

Herpes Simplex Keratitis

UNKNOWN NA

A Study of Stem Cells Lenses in the coGVHD Subjects

NCT06952114

Chronic Ocular Graft-versus-host Disease

NOT_YET_RECRUITING EARLY_PHASE1

Corneal Cross-Linking Comparing Variables

NCT02095730

Unstable Corneas

UNKNOWN PHASE3

Safety and Efficacy of a New Transepithelial Photorefractive Keratectomy Treatment

NCT04698174

Ametropia

COMPLETED NA

Nerve Growth Factor for the Treatment of Cornea Disease

NCT04552730

Neurotrophic Keratitis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is an open-label, single ascending dose study of BD111 in adult (ages 18 to 70) participants with refractory herpetic viral keratitis. Approximately 6 participants will be enrolled.BD111 is a novel gene editing product designed to clear Herpes simplex virus type I (HSV-1) that results in herpetic stromal keratitis in both acute and recurrent infection models which is the leading factor for infectious blindness.

The follow-up period was 360 days, and the patients will be followed up 3±1 days, 7±2 days, 30±7 days, 90±14 days, 180±21 days, and 360+31 days after treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Viral Keratitis Blindness Eye Herpes Simplex Virus Infection Cornea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group target value: Since there is no similar products approved on the market and there is no similar comparative treatment methods, the single group target value method is adopted

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BD111 Adults single group Dose

Administered by corneal injection surgery. Dosage form:injection solution. Dose:200uL. Frequency of administration: one time injection.

Group Type EXPERIMENTAL

BD111 Adult single group Dose

Intervention Type DRUG

3-6 Participants will receive a single group dose administered via corneal injection in the study eye.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BD111 Adult single group Dose

3-6 Participants will receive a single group dose administered via corneal injection in the study eye.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Patients (replase) with refractory keratitis caused by herpes virus type I who has had at least one time failed corneal transplant.

1. Age between 18 to 70 years.
2. No systemic immune eye disease.
3. Good eyelid structure and blink function.
4. Exists the potential of visual recovery by evaluation of ocular structure and function.
5. 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.
6. Patients who are obviously suffering from relapse HSV infections with corneal perforation, requiring corneal transplantation;
7. No history of corneal trauma.
8. Subjects or their legal guardians voluntarily participate in this study, sign informed consent, good compliance and cooperation with follow-up visits.

Exclusion Criteria

1. Lacrimal coating and blink function loss.
2. Schirmer's test result is less than 2mm for severe dry eye disease.
3. Pregnant and lactating women (pregnancy defined in this study as positive urine pregnancy test).
4. Currently is involved in clinical trials of other drugs or medical devices.
5. 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.
6. Ocular surface malignant tumor.
7. 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.
8. current in an infectious disease requiring oral, intramuscular or intravenous administration.
9. Patients with systemic immune diseases.
10. Any uncontrolled clinical problems (such as severe mental, neurological, cardiovascular, respiratory and other systemic diseases and malignant neoplasms).
11. Not effective contraception.
12. In uncontrolled hypertension, systolic is no less than 160 mmhg, diastolic is no less than 100 mmhg.
13. In uncontrolled diabetes, fasting glucose is no less than 10.0umol/L.
14. Renal insufficiency, serum creatinine is more than 133umol/L.
15. Arrhythmia, myocardial ischemia, myocardial infarction (diagnosed by electrocardiogram).
16. Liver dysfunction, al ANINE aminotransferase and aspartate aminotransferase levels are higher than 80 IU/L.
17. Platelet level is below 100,000 /uL or above 450,000 /uL.
18. Hemoglobin level is below 10.0g/dL (male) or 9.0g/dL (female).
19. No anticoagulant was used, prothrombin time is higher than 16s, and thrombin time of activated part is higher than 50s.
20. HIV infection (HIV-positive).
21. Subjects lack compliance with the study or the ability to sign informed consent.
22. 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).
23. Administration of Glucocorticoids and other systemic immunosuppressive drugs.
24. The investigator judges other conditions unsuitable for the trial

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No