Gypenosides Treatment for Optic Neuritis

First Affiliated Hospital of Guangxi Medical University

Status and phase: Terminated; Phase 2

Conditions: Optic Neuritis

Treatments: Drug: Gypenosides; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT02976766

GXON-001

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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10 participants in 2 patient groups, including a placebo group

Gypenosides

Experimental group

Treatment:

Drug: Gypenosides

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo