TerminatedPhase 2

Gypenosides Treatment for Optic Neuritis

Stopped: Low enrolment

China10 participantsStarted 2017-02-04

Plain-language summary

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

Age range18 Years – 60 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Male and female Chinese patients aged ≥18 to ≤60 years
✓. Patients with a first episode of optic neuritis in the eye of interest
✓. First symptoms of optic neuritis ≤28 days prior to the first administration of investigational product
✓. Best corrected visual acuity in the eye of interest ≤0.8

✕. Pre-existing multiple sclerosis MS or NMO
✕. Refractive media opacity
✕. Hyperopia \>5 diopters, myopia \<-5 diopters, or astigmatism \>3 diopters
✕. Active tuberculosis, hepatitis, renal insufficiency, uncontrolled hypertension, diabetes mellitus, infection with HIV or syphilis, or any other conditions potentially interfering treatment trial
✕. Other autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis, etc)
✕. Existing other retina or optic nerve diseases
✕. Pregnant or females who plan to be pregnant during study

Mean retinal nerve fibre layer thickness

Timeframe: 6 months

NCT IDNCT02976766

SponsorFirst Affiliated Hospital of Guangxi Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31