Stopped: Slow recruitment and an unexpectedly high proportion of AQP4-IgG-positive optic neuritis on masked feasibility review limited feasibility. No interim efficacy analysis was performed.
China10 participantsStarted 2017-02-04
Plain-language summary
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.
Who can participate
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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
Exclusion criteria
. Pre-existing multiple sclerosis MS or NMO
. Refractive media opacity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Mean peripapillary retinal nerve fiber layer thickness
Timeframe: 6 months
Trial details
NCT IDNCT02976766
SponsorFirst Affiliated Hospital of Guangxi Medical University
. 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