A Phase 2b/3, Prospective, Randomised, Double-masked, Active Comparator-controlled, Multi-center Study to Investigate the Efficacy and Safety of Repeated Intravitreal Administration of KSI-301 in Subjects with Neovascular (Wet) Age-related Macular Degeneration (DAZZLE)

Kodiak Sciences Inc.0 个研究点目标入组 550 人开始时间: 2019年10月10日最近更新: 2022年5月30日

适应症

试验速览

暂无简介。

•1.Active, treatment-naïve choroidal neovascularization (CNV) secondary to AMD, including subfoveal, juxtafoveal and extrafoveal lesions or retinal angiomatous proliferation (RAP) lesions with a CNV component that affect the central subfield as evidenced by FA or OCT in the Study Eye at Screening.
•2.The CNV area in the Study Eye must be at least 50% of total lesion size at Screening.
•3.A lesion area <30 mm2 (12 disc areas) of any CNV lesion subtype in the Study Eye.
•4.Intra and/or subretinal fluid and/or SHRM (subretinal hyperreflective material) affecting the central subfield of the Study Eye on OCT at Screening.
•5.BCVA ETDRS score between 80 and 25 letters (20/25 to 20/320 Snellen equivalent), inclusive, in the Study Eye at Screening and reconfirmed at Day 1.
•6.Decrease in vision in the Study Eye determined by the Investigator to be primarily the result of wAMD.
•7.Capable of understanding the informed consent, provides signed and dated informed consent, and agrees to comply with protocol requirements.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 55
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 495

•1.BCVA of hand motion or worse in the non-Study Eye or non-physical presence of a non-Study Eye (i.e., monocular).
•2.Active or suspected ocular or periocular infection or inflammation in either eye at Day 1.
•3.CNV secondary to other causes in the Study Eye, including pathologic myopia, angioid streaks, prior trauma, ocular histoplasmosis, or others.
•4.Any history of macular pathology unrelated to AMD but affecting vision or contributing to subretinal or intraretinal fluid, such as central serous chorioretinopathy.
•5.Fibrosis or atrophy of >50% of the lesion size and/or involving the foveal center of the Study Eye at Screening
•6.Subretinal blood affecting the foveal center of the Study Eye and/or more than 50% of the lesion size at Screening.
•7.Any approved or investigational treatment for neovascular AMD (other than oral vitamin supplements) in the Study Eye at any time.
•8.Prior macular laser (e.g., thermal laser or photodynamic therapy laser) in the Study Eye.

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