Gypenosides Treatment for Optic Neuritis

• Status: Terminated
• Trial end date: 2020-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether gypenosides are neuroprotective in patients with acute optic neuritis.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: First Affiliated Hospital of Guangxi Medical University

Criteria

Inclusion criteria

1. Male and female Chinese patients aged ≥18 to ≤60 years

2. Patients with a first episode of optic neuritis in the eye of interest

3. First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product

4. Best corrected visual acuity in the eye of interest ≤0.8

Exclusion criteria

1. Pre-existing multiple sclerosis MS or NMO

2. Refractive media opacity

3. Hyperopia >5 diopters, myopia <-5 diopters, or astigmatism >3 diopters

4. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial

5. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)

6. Existing other retina or optic nerve diseases

7. Pregnant or females who plan to be pregnant during study