Adjunctive Gypenosides for Acute Optic Neuritis

Adjunctive Gypenosides for Acute Optic Neuritis: A Randomized, Double-Blind, Placebo-Controlled Pilot Trial

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.

Study Overview

• Status: Terminated
• Conditions: Optic Neuritis
• Intervention / Treatment: Drug: Gypenosides; Drug: Placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Guangxi
    • Nanning, Guangxi, China, 530021
      • The First Affiliated Hospital of Guangxi Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 56 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gypenosides; Participants received adjunctive oral gypenosides for 10 days in addition to standard corticosteroid treatment.	Drug: Gypenosides; Participants received gypenosides 180 mg/day, given as 60 mg three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment.; Other Names: Jiaogulan Zongdai
Placebo Comparator: Placebo; Participants received matching placebo capsules for 10 days in addition to standard corticosteroid treatment.	Drug: Placebo; Participants received matching placebo capsules three times daily for 10 days, started on the first day of intravenous methylprednisolone. All participants also received standard corticosteroid treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean peripapillary retinal nerve fiber layer thickness	Peripapillary retinal nerve fiber layer thickness in the prespecified index eye at Month 6, measured in micrometers by spectral-domain OCT. The index eye was the affected study eye; in bilateral cases, the eye with worse baseline best-corrected visual acuity was used, and if visual acuity was equal, the right eye was used. Higher values indicate less retinal nerve fiber layer thinning.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total macular volume	Total macular volume in the prespecified index eye at Month 6, measured by spectral-domain OCT macular volume scans. Higher values indicate greater macular volume. Macular ganglion cell-inner plexiform layer thickness was not a registered secondary outcome and was analyzed only as an exploratory segmentation-derived macular structural endpoint.	6 months
Best-corrected visual acuity	Best-corrected visual acuity in the prespecified index eye at Month 6, assessed using a high-contrast tumbling-E chart and converted to logarithm of the minimum angle of resolution for analysis.	6 months
Latency and amplitude of visual evoked potentials	Pattern-reversal visual evoked potentials in the prespecified index eye at Month 6. P100 latency was measured in milliseconds, and N75-P100 peak-to-peak amplitude was measured in microvolts.	6 months
Mean visual field defect	Visual-field mean defect or mean deviation in the prespecified index eye at Month 6, measured in decibels using automated perimetry.	6 months
Number of participants with adverse events	Number of participants with adverse events or serious adverse events from screening through the end of study follow-up. Relationship to study medication was assessed by investigators.	Screening until end of study

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Guangxi Medical University
• Investigators: Principal Investigator: Yi Du, MD, The First Affiliated Hospital of Guangxi Medical University, China

Study record dates

Study Major Dates

• Study Start (Actual): February 4, 2017
• Primary Completion (Actual): July 30, 2018
• Study Completion (Actual): July 30, 2018

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: November 25, 2016
• First Posted (Estimated): November 29, 2016

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Optical coherence tomography; Clinical trial; Neuroprotection; Traditional Chinese medicine; Axonal loss; Jiaogulan; Gynostemma pentaphyllum
• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Optic Nerve Diseases; Cranial Nerve Diseases; Optic Neuritis
• Other Study ID Numbers: GXON-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No