Trial reportJapanese journal of ophthalmology2021
Intravenous immunoglobulin treatment for steroid-resistant optic neuritis: a multicenter, double-blind, randomized, controlled phase III study.
Trial report in Japanese journal of ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.
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The trial behind it
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Who cites it
9 citing papers in PubMed, 15 citations in OpenAlex.
- Intravenous immunoglobulin for the acute treatment of refractory optic neuritis in Japan.Japanese journal of ophthalmology · 2025Article
- Evaluation of Brain and Spinal Cord Lesions and Cerebrospinal Fluid Analysis in Detecting Demyelinating Diseases in Patients with Optic Neuritis.Neuro-ophthalmology (Aeolus Press) · 2025Article
- Visual Function Improvement after Plasma Exchange Therapy for Acute Optic Neuritis in Neuromyelitis Optica Spectrum Disorders: Case Series and Review.Diagnostics (Basel, Switzerland) · 2024Review
- Article
- Visualization and analysis of mapping knowledge domains for optic neuritis: a bibliometric research from 2013 to 2022.International ophthalmology · 2024Article
- Efficacy and Safety of Intravenous Immunoglobulin Treatment in Selected Neurological Diseases-One Centre's Experience Based on the Therapy of 141 Patients.Journal of clinical medicine · 2023Article
- Update on glial antibody-mediated optic neuritis.Japanese journal of ophthalmology · 2022Review
- Intravenous Immunoglobulin in the Treatment of Adalimumab-associated Optic Neuritis.Internal medicine (Tokyo, Japan) · 2022Article
- Update on Optic Neuritis: An International View.Neuro-ophthalmology (Aeolus Press) · 2022Review
Corrections and comments
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Authors and funding
12 authors at 10 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeTo evaluate the efficacy and safety of intravenous "freeze-dried sulfonated human normal immunoglobulin (GGS)" in patients with steroid-resistant optic neuritis (ON). STUDY
designMulticenter, prospective, double-blind, parallel-group, randomized controlled trial.
methodsPatients with steroid-resistant acute ON were randomly assigned to receive either intravenous GGS (GGS group) or intravenous methylprednisolone (steroid pulse [SP] group). Visual acuity (logarithm of the minimum angle of resolution [logMAR]), mean deviation (MD) value of the Humphrey Field Analyzer, and critical flicker fusion frequency were measured as efficacy endpoints; adverse events (AEs) were assessed as the safety endpoint.
resultsThirty-two patients (16 patients/group) received the study drugs. The primary endpoint, change in logMAR at week 2 compared to baseline, showed no statistically significant intergroup difference. However, compared with the SP group, change in the GGS group was increasingly indicative of visual improvement, with least squares mean difference of > 0.3 logMAR. On post-hoc analyses, the percentage of patients in the GGS and SP groups with improvement by ≥ 0.3 logMAR at week 2 were 75.0% and 31.3%, respectively. Changes in MD values at week 2 compared to baseline were 9.258 ± 8.296 (mean ± standard deviation) dB and 3.175 ± 6.167 dB in the GGS and SP groups, respectively. These results showed statistically significant intergroup differences (visual acuity improvement, P = 0.032; change in MD values, P = 0.030). No clinically significant AEs were observed.
conclusionOur results suggest that intravenous immunoglobulin could be a safe and efficacious therapeutic option for prompt treatment of steroid-resistant acute ON.
trial registrationJapicCTI-132080.
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