Abstract | PURPOSE: 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: TRIAL REGISTRATION: JapicCTI-132080.
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Authors | Osamu Mimura, Hitoshi Ishikawa, Takeshi Kezuka, Keigo Shikishima, Tone Suzuki, Makoto Nakamura, Hideki Chuman, Kenji Inoue, Akiko Kimura, Akiko Yamagami, Maki Mihoya, Yuzo Nakao |
Journal | Japanese journal of ophthalmology
(Jpn J Ophthalmol)
Vol. 65
Issue 1
Pg. 122-132
(Jan 2021)
ISSN: 1613-2246 [Electronic] Japan |
PMID | 33469728
(Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial)
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Chemical References |
- Immunoglobulins, Intravenous
- Steroids
- Methylprednisolone
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Topics |
- Double-Blind Method
- Humans
- Immunoglobulins, Intravenous
- Methylprednisolone
- Optic Neuritis
(diagnosis, drug therapy)
- Prospective Studies
- Steroids
- Treatment Outcome
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