Osamu Mimura1, Hitoshi Ishikawa2, Takeshi Kezuka3, Keigo Shikishima4, Tone Suzuki5, Makoto Nakamura6, Hideki Chuman7, Kenji Inoue8, Akiko Kimura9, Akiko Yamagami8, Maki Mihoya10, Yuzo Nakao11. 1. Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Japan. omimurahomburg@gmail.com. 2. Department of Orthoptics and Visual Science, School of Allied Health Sciences, Kitasato University, Sagamihara, Japan. 3. Department of Ophthalmology, Tokyo Medical University, Shinjuku, Japan. 4. Department of Ophthalmology, The Jikei University School of Medicine, Minato, Japan. 5. Department of Ophthalmology, Dokkyo Medical University Saitama Medical Center, Koshigaya, Japan. 6. Division of Ophthalmology, Department of Surgery, Kobe University Graduate School of Medicine, Kobe, Japan. 7. Department of Ophthalmology, University of Miyazaki, Miyazaki, Japan. 8. Inoue Eye Hospital, Chiyoda, Japan. 9. Department of Ophthalmology, Hyogo College of Medicine, Nishinomiya, Japan. 10. Pharmaceutical Development Administration Department, Teijin Pharma Limited, Chiyoda, Japan. 11. Department of Ophthalmology, Kindai University Faculty of Medicine, Osakasayama, Japan.
Abstract
PURPOSE: To evaluate the efficacy and safety of intravenous "freeze-dried sulfonated human normal immunoglobulin (GGS)" in patients with steroid-resistant optic neuritis (ON). STUDY DESIGN: Multicenter, prospective, double-blind, parallel-group, randomized controlled trial. METHODS:Patients 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. RESULTS: Thirty-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. CONCLUSION: Our results suggest that intravenous immunoglobulin could be a safe and efficacious therapeutic option for prompt treatment of steroid-resistant acute ON. TRIAL REGISTRATION: JapicCTI-132080.
RCT Entities:
PURPOSE: To evaluate the efficacy and safety of intravenous "freeze-dried sulfonated human normal immunoglobulin (GGS)" in patients with steroid-resistant optic neuritis (ON). STUDY DESIGN: Multicenter, prospective, double-blind, parallel-group, randomized controlled trial. METHODS:Patients 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. RESULTS: Thirty-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. CONCLUSION: Our results suggest that intravenous immunoglobulin could be a safe and efficacious therapeutic option for prompt treatment of steroid-resistant acute ON. TRIAL REGISTRATION: JapicCTI-132080.