Leber Optic Hereditary Neuropathy
Conditions
Interventions
one:Gene therapy, take orally corticosteroids for 8weeks
two:Gene therapy, take orally corticosteroids for 3weeks
three:Gene therapy,only topical use of corticosteroids
Sponsors
Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei Province, China
Eligibility
Sex/Gender
All
Age
13 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Those who meet Leber's diagnostic criteria for hereditary optic neuropathy and are identified as 11778 site mutation by gene sequencing, have not received other treatment in the past 3 months, and their vision has not improved; 2. Patients with vision below 0.3 in both eyes;Vision progressive decline, and irreversible damage seriously affect life; 3. Aged between 12 -65 years, course of disease is longer than 6 months, all men and women can tolerate local anesthesia operation; 4. Agrees not to use other drugs or treatments for the disease during the treatment period; 5. The patient and his legal representative participate voluntarily and sign the informed consent. 6. Follow the doctor's instructions and return to the hospital at the prescribed time.
Exclusion criteria
Exclusion criteria: 1) Chronic diseases such as diabetes; 2) Severe primary diseases such as cardiovascular, cerebrovascular, liver and kidney; 3) Other systemic neurological diseases; 4) Patients in convalescence after heart surgery, etc.; 5) Patients with mental disorders; 6) Tumor patients; 7) Patients with other eye diseases. 2. Patients who have participated in other clinical studies in recent 3 months; 3. Alcoholism, smoking, drug use or a history of drug abuse or exposure to toxic substances; 4. Pregnant women, lactating women or those planning to become pregnant within 12 months; 5. Preoperative immune test results were significantly abnormal (such as AAV2 positive humoral immune reaction, CD3/CD8 abnormal); 6. Other reasons why the researcher considers it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Best Corrected Visual Acuity;visual field;Intraocular pressure; | — |
Secondary
| Measure | Time frame |
|---|---|
| visual evoked potential;retinal nerve fiber layer;fundus;system laboratory examination; | — |
Countries
China
Contacts
Public ContactBin Li
Taihe Hospital, Hubei University of Medicine, Shiyan, Hubei Province, China
Outcome results
None listed