Optic Neuritis
Conditions
Keywords
Neuroprotection, Clinical trial, Traditional Chinese medicine, Axonal loss, Jiaogulan, Gynostemma pentaphyllum, Optical coherence tomography
Brief 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.
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.
Interventions
DRUGGypenosides
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.
DRUGPlacebo
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.
Sponsors
First Affiliated Hospital of Guangxi Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Participants, treating clinicians, outcome assessors, and statisticians were masked to treatment assignment. Gypenosides and placebo capsules were prepared and packaged to maintain identical appearance and labeling.
Intervention model description
Participants were randomized in a 1:1 ratio to adjunctive gypenosides or matching placebo in parallel groups. Both groups received standard corticosteroid treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean peripapillary retinal nerve fiber layer thickness | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total macular volume | 6 months | 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. |
| Best-corrected visual acuity | 6 months | 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. |
| Latency and amplitude of visual evoked potentials | 6 months | 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. |
| Mean visual field defect | 6 months | Visual-field mean defect or mean deviation in the prespecified index eye at Month 6, measured in decibels using automated perimetry. |
| Number of participants with adverse events | Screening until end of study | 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. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORYi Du, MD
The First Affiliated Hospital of Guangxi Medical University, China
Outcome results
None listed