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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01267422 |
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Date of registration:
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27/12/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety and Efficacy Study of rAAV2-ND4 Treatment of Leber Hereditary Optic Neuropathy (LHON)
rAAV2-ND4 |
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Scientific title:
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Safety and Efficacy Study of a Single Intravitreal Injection of rAAV2-ND4 Treatment of Leber Hereditary Optic Neuropathy |
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Date of first enrolment:
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April 2011 |
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Target sample size:
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9 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01267422 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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bin Li, PhD,MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Deputy Director of Ophthalmology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. comply with Leber hereditary optic neuropathy diagnostic criteria.
2. in patients with informed consent, voluntary participation.
3. signed informed consent.
4. 8 = Age = 60 years old, good health, the patient can tolerate local anesthesia
surgery.
5. to comply with doctor's instructions, can in the time of referral.
Exclusion Criteria:
1. Cardiopulmonary and renal function in severe weakness, cancer, a variety of bleeding
disorders, acute sensing disease, high fever, high fever disease, women during
pregnancy, heart disease, such as post-operative recovery period.
2. Are participating in other clinical studies of patients.
3. Patients with mental disorders.
Age minimum:
8 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Leber Hereditary Optic Neuropathy
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Intervention(s)
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Drug: rAAV2-ND4
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Primary Outcome(s)
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Results of CD3/CD4/CD8 Test
[Time Frame: up to 6 months]
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The Best Corrected Visual Acuity(BCVA)
[Time Frame: Up to 3 years]
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Secondary Outcome(s)
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Intraocular Pressure;
[Time Frame: Up to 3 years]
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Neutralizing Antibody Assay
[Time Frame: up to 3 years]
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Average RNFL Thickness Througth Optical Coherence Tomography(OCT) Test
[Time Frame: Up to 3 years]
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Computerized Visual Field(MD: Mean Deviation, the Value Close to 0 Regarded Normal)
[Time Frame: up to 3 years]
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Computerized Visual Field(VFI: Visual Field Index ,the Value Close to 100% Regarded Normal)
[Time Frame: up to 3 years]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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