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Intravenous immunoglobulin treatment for steroid-resistant optic neuritis: a multicenter, double-blind, randomized,
Osamu Mimura1, Hitoshi Ishikawa2, Takeshi Kezuka3
1Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Japan. omimurahomburg@gmail.com.
Intravenous freeze-dried sulfonated human normal immunoglobulin (GGS) showed potential for treating steroid-resistant optic neuritis (ON). This immunoglobulin therapy demonstrated significant visual acuity and visual field improvements compared to standard treatment.
Area of Science:
- Ophthalmology
- Neuroimmunology
- Immunotherapy
Background:
- Steroid-resistant optic neuritis (ON) presents a significant challenge in clinical management.
- Intravenous immunoglobulin (IVIG) is explored as an alternative therapeutic strategy.
Purpose of the Study:
- To evaluate the efficacy and safety of intravenous freeze-dried sulfonated human normal immunoglobulin (GGS) for acute, steroid-resistant optic neuritis (ON).
Main Methods:
- A multicenter, prospective, double-blind, randomized controlled trial was conducted.
- Patients received either intravenous GGS or intravenous methylprednisolone (steroid pulse therapy).
- Efficacy was assessed by visual acuity (logMAR), Humphrey Field Analyzer (MD values), and critical flicker fusion frequency; safety by adverse events.
Main Results:
- While the primary endpoint (logMAR at week 2) showed no significant difference, post-hoc analyses revealed greater visual improvement in the GGS group (75.0% vs 31.3% improved by ≥0.3 logMAR).
- Statistically significant intergroup differences were observed in visual acuity improvement (P=0.032) and mean deviation values (P=0.030) at week 2.
- No clinically significant adverse events were reported in either group.
Conclusions:
- Intravenous immunoglobulin (GGS) appears to be a safe and effective treatment option for patients with steroid-resistant acute optic neuritis.
- GGS offers a promising therapeutic alternative for prompt management of this condition.
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