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

研究成果: ジャーナルへの寄稿記事

抄録

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.

元の言語英語
ページ(範囲)439-448
ページ数10
ジャーナルNippon Ganka Gakkai zasshi
120
発行部数6
出版物ステータス出版済み - 6 1 2016

Fingerprint

Vitrectomy
Multicenter Studies
Research Personnel
Clinical Trials
Staining and Labeling
Safety
Membranes
Clinical Trials Data Monitoring Committees
Eye Pain
Retinal Perforations
Ambulatory Surgical Procedures
Intraocular Pressure
Reoperation
Hemorrhage
Injections
brilliant blue

All Science Journal Classification (ASJC) codes

  • Medicine(all)

これを引用

Efficacy and Safety of A0001 (Brilliant Blue G250) for Internal Limiting Membrane Staining and Peeling : Phase III Investigator-initiated Multicenter Clinical Trial. / Enaida, Hiroshi; Hirakata, Akito; Ohji, Masahito; Nishida, Kohji; Kubota, Toshiaki; Ogata, Nahoko; Sonoda, Koh Hei; Uchiyama, Makiko; Kishimoto, Junji; Todaka, Koji; Nakanishi, Yoichi; Ishibashi, Tatsuro.

:: Nippon Ganka Gakkai zasshi, 巻 120, 番号 6, 01.06.2016, p. 439-448.

研究成果: ジャーナルへの寄稿記事

Enaida, Hiroshi ; Hirakata, Akito ; Ohji, Masahito ; Nishida, Kohji ; Kubota, Toshiaki ; Ogata, Nahoko ; Sonoda, Koh Hei ; Uchiyama, Makiko ; Kishimoto, Junji ; Todaka, Koji ; Nakanishi, Yoichi ; Ishibashi, Tatsuro. / 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. 2016 ; 巻 120, 番号 6. pp. 439-448.
@article{57cc36e582bb418195ff0dd8f686437a,
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",
year = "2016",
month = "6",
day = "1",
language = "English",
volume = "120",
pages = "439--448",
journal = "Journal of Japanese Ophthalmological Society",
issn = "0029-0203",
publisher = "Nippon Ganka Gakkai",
number = "6",

}

TY - JOUR

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.

UR - http://www.scopus.com/inward/record.url?scp=85021856966&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85021856966&partnerID=8YFLogxK

M3 - Article

C2 - 27487716

AN - SCOPUS:85021856966

VL - 120

SP - 439

EP - 448

JO - Journal of Japanese Ophthalmological Society

JF - Journal of Japanese Ophthalmological Society

SN - 0029-0203

IS - 6

ER -