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nAMD患者を対象としたRGX-314遺伝子治療のピボタル2試験

基本情報

NCT ID
NCT05407636
ステータス
募集中
試験のフェーズ
第3相
試験タイプ
介入
目標被験者数
660
治験依頼者名
AbbVie

概要

ABBV-RGX-314 (also known as RGX-314) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

対象疾患

AMDnAMDWet Age-related Macular DegenerationwAMDWetAMDCNV

介入

ABBV-RGX-314 Dose 1(GENETIC)
ABBV-RGX-314 Dose 2(GENETIC)
Aflibercept (EYLEA®)(BIOLOGICAL)

依頼者(Sponsor)

実施施設 (14)

名古屋大学医学部附属病院

Nagoya, Aichi-ken, Japan(RECRUITING)

神戸市立神戸アイセンター病院

Kobe, Hyōgo, Japan(RECRUITING)

Juntendo University Hospital /ID# 258715

Bunkyo-ku, Tokyo, Japan(RECRUITING)

兵庫医科大学病院

Nishinomiya-shi, Hyōgo, Japan(RECRUITING)

滋賀医科大学医学部附属病院

Ōtsu, Shiga, Japan(RECRUITING)

Kyoto University Hospital /ID# 267351

Kyoto, Kyoto, Japan(RECRUITING)

Hyogo Medical University Hospital /ID# 257893

Nishinomiya-shi, Hyōgo, Japan(RECRUITING)

京都大学医学部附属病院

Kyoto, Kyoto, Japan(RECRUITING)

鹿児島大学病院

Kagoshima, Kagoshima-ken, Japan(RECRUITING)

Fukushima Medical University Hospital /ID# 258411

Fukushima, Fukushima, Japan(RECRUITING)

宮崎大学医学部附属病院

Miyazaki, Miyazaki, Japan(RECRUITING)

公立大学法人 福島県立医科大学附属病院

Fukushima, Fukushima, Japan(RECRUITING)

順天堂大学医学部附属順天堂医院

Bunkyo-ku, Tokyo, Japan(RECRUITING)

県立宮崎病院

Miyazaki, Miyazaki, Japan(RECRUITING)