Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial

Hiroshi Enaida; Akito Hirakata; Masahito Ohji; Kohji Nishida; Toshiaki Kubota; Nahoko Ogata; Koh Hei Sonoda; Makiko Uchiyama; Junji Kishimoto; Koji Todaka; Yoichi Nakanishi; Tatsuro Ishibashi

Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial

Hiroshi Enaida, Akito Hirakata, Masahito Ohji, Kohji Nishida, Toshiaki Kubota, Nahoko Ogata, Koh Hei Sonoda, Makiko Uchiyama, Junji Kishimoto, Koji Todaka, Yoichi Nakanishi, Tatsuro Ishibashi

Research output: Contribution to journal › Article › peer-review

2 Citations (Scopus)

Abstract

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.

Original language	English
Pages (from-to)	439-448
Number of pages	10
Journal	Nippon Ganka Gakkai zasshi
Volume	120
Issue number	6
Publication status	Published - Jun 1 2016

All Science Journal Classification (ASJC) codes

Medicine(all)

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Enaida, H., Hirakata, A., Ohji, M., Nishida, K., Kubota, T., Ogata, N., Sonoda, K. H., Uchiyama, M., Kishimoto, J., Todaka, K., Nakanishi, Y., & Ishibashi, T. (2016). Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial. Nippon Ganka Gakkai zasshi, 120(6), 439-448.

Enaida, H, Hirakata, A, Ohji, M, Nishida, K, Kubota, T, Ogata, N, Sonoda, KH, Uchiyama, M, Kishimoto, J , Todaka, K, Nakanishi, Y & Ishibashi, T 2016, 'Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial', Nippon Ganka Gakkai zasshi, vol. 120, no. 6, pp. 439-448.

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title = "Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial",

abstract = "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.",

author = "Hiroshi Enaida and Akito Hirakata and Masahito Ohji and Kohji Nishida and Toshiaki Kubota and Nahoko Ogata and Sonoda, {Koh Hei} and Makiko Uchiyama and Junji Kishimoto and Koji Todaka and Yoichi Nakanishi and Tatsuro Ishibashi",

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T1 - Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling

T2 - Phase III Investigator-initiated Multicenter Clinical Trial

AU - Enaida, Hiroshi

AU - Hirakata, Akito

AU - Ohji, Masahito

AU - Nishida, Kohji

AU - Kubota, Toshiaki

AU - Ogata, Nahoko

AU - Sonoda, Koh Hei

AU - Uchiyama, Makiko

AU - Kishimoto, Junji

AU - Todaka, Koji

AU - Nakanishi, Yoichi

AU - Ishibashi, Tatsuro

PY - 2016/6/1

Y1 - 2016/6/1

N2 - 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.

AB - 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.

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ER -

Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling: Phase III Investigator-initiated Multicenter Clinical Trial

Abstract

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