CTRI/2023/09/057662招募中3 期
A Phase IIIB, Multicenter, Open-Label, Single-Arm Study To Investigate Faricimab (RO6867461) Treatment Response In Treatment-Naive, Underrepresented Asian Indian Patients With Diabetic Macular Edema - Elevatum
F HoffmannLa Roche Ltd0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients who self-identify as Asian Indian residents of the Indian subcontinent.
- •Diagnosis of diabetes mellitus (Type 1 or Type 2), as defined by the World Health Organization (WHO) and/or American Diabetes Association, and
- •– Current regular use of insulin or other injectable drugs (e.g., dulaglutide and liraglutide) for the treatment of diabetes
- •– Current regular use of oral anti-hyperglycemic agents for the treatment of diabetes
- •Patients who are IVT treatment-naïve in the study eye.
- •Clear ocular media and adequate pupillary dilation to allow acquisition of good quality retinal images to confirm diagnosis.
- •For women of childbearing potential: Agreement to remain abstinent or use acceptable contraception methods
排除标准
- •Patients with diabetes mellitus (Type 1 or Type 2) that is currently medically untreated.
- •Patients with previously untreated diabetes mellitus (Type 1 or Type 2) who started on oral or injectable anti-diabetic medication within 3 months prior to Day 1.
- •Any known hypersensitivity to any of the components in the faricimab injection.
- •Any known hypersensitivity to any contrast media (e.g., fluorescein), dilating eye drops, disinfectants (e.g., iodine), or any of the anesthetics and antimicrobial preparations used by the patient during the study.
- •Any febrile illness within 1 week prior to Day 1. Pregnant or breastfeeding, or intending to become pregnant during the study or within 3 months after the final dose of faricimab.
研究者
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