Adjunctive Gypenosides for Acute 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

This pilot randomized, double-blind, placebo-controlled trial evaluated whether short-course adjunctive gypenosides, added to standard corticosteroid treatment, may preserve retinal structural outcomes in adults with acute optic neuritis.

Full description

This was a single-center, randomized, double-blind, placebo-controlled pilot trial in adults with a first episode of acute optic neuritis within 28 days of symptom onset. Participants received standard corticosteroid treatment and were randomized in a 1:1 ratio to adjunctive oral gypenosides 180 mg/day for 10 days or matching placebo.

The trial was designed as a pilot study to estimate structural treatment effects and variability for future neuroprotection trials in optic neuritis. The primary structural outcome was peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6 measured by spectral-domain OCT. Secondary outcomes included total macular volume, best-corrected visual acuity, visual evoked potentials, visual-field measures, and safety outcomes.

Macular ganglion cell-inner plexiform layer thickness was analyzed as an exploratory segmentation-derived macular structural endpoint.

Baseline aquaporin 4 immunoglobulin G serostatus was assessed. Myelin oligodendrocyte glycoprotein immunoglobulin G testing was not included in the original study design.

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

Description:

Participants received adjunctive oral gypenosides for 10 days in addition to standard corticosteroid treatment.

Treatment:

Drug: Gypenosides

Placebo

Placebo Comparator group

Description:

Participants received matching placebo capsules for 10 days in addition to standard corticosteroid treatment.

Treatment:

Drug: Placebo