Original article : Clinical science
Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial
Hiroshi Enaida1, Akito Hirakata2, Masahito Ohji3, Kohji Nishida4, Toshiaki Kubota5, Nahoko Ogata6, Koh-Hei Sonoda7,10, Makiko Uchiyama8, Junji Kishimoto9, Koji Todaka8, Yoichi Nakanishi8, Ishibashi Tatsuro10
1 Department of Ophthalmology, Saga University Faculty of Medicine
2 Kyorin Eye Center, Kyorin University, School of Medicine
3 Department of Ophthalmology, Shiga University of Medical Science
4 Department of Ophthalmology, Osaka University Graduate School of Medicine
5 Department of Ophthalmology, Oita University, Faculty of Medicine
6 Department of Ophthalmology, Nara Medical University
7 Department of Ophthalmology, Yamaguchi University Graduate School of Medicine
8 Center for Clinical and Translational Research, Kyushu University Hospital
9 Department of Research and Development of Next Generation Medicine, Faculty of Medical Sciences, Kyushu University
10 Department of Ophthalmology, Graduate School of Medical Sciences, Kyushu University
Purpose: To investigate the efficacy and safety of A0001 (brilliant blue G250) for visualization of the internal limiting membrane (ILM) during and after vitrectomy.
Methods: Patients (n=31) requiring ILM peeling during vitrectomy were enrolled in this clinical trial. After injection of A0001 (range: 0.0625 to 0.125 mg), the staining grade and the peeling ease of the ILM were evaluated in five steps (levels 0 to 4). The safety of A0001 was investigated for 7 days after surgery.
Results: From the evaluation of a primary endpoint by the Independent Data Monitoring Committee (IDMC) and a secondary endpoint by each surgeon, A0001 was effective in all cases at three or more levels (≥level 2 was defined as effective) for evaluation of the grade of visualization and operating ease. Adverse events occurring in two or more cases included elevated intraocular pressure, eye pain, eye discharges, and retinal bleeding. One serious adverse event was a case of unclosed macular hole after vitrectomy, but the patient recovered after reoperation.
Conclusions: A0001 was effective and safe for visualization of the ILM during vitrectomy, and there was an improvement in ease of operation.
Nippon Ganka Gakkai Zasshi (J Jpn Ophthalmol Soc) 120: 439-448, 2016.
Key words
Brilliant blue G, Investigator-initiated clinical trial, Staining of internal limiting membrane, Internal limiting membrane peeling, Vitrectomy
Reprint requests to
Hiroshi Enaida, M.D. Department of Ophthalmology, Saga University Faculty of Medicine. 5-1-1 Nabeshima, Saga-shi 849-8501, Japan
Received: 9 December 2015. Accepted in revised form: 26 January 2016.
Nihon Ganka Gakkai Zasshi
120: 439-448,2016
