A prospective, multi-center, single arm, open label, phase 4 study to evaluate safety and efficacy of RaniEyes® (Lupin’s ranibizumab for intravitreal injection) in real world clinical practice.

Lupin Limited6 个研究点分布在 1 个国家目标入组 200 人开始时间: 2026年1月20日最近更新: 2026年2月2日

试验速览

阶段: Unknown
状态: 招募中
发起方: Lupin Limited
入组人数: 200
试验地点: 6

研究概览研究设计入排标准研究者研究点记录与标识符相似试验

研究概览

简要总结

RaniEyes® (Lupin’s ranibizumab) is an approved ranibizumab biosimilar in India. This Phase 4 clinical study is being conducted in patients with neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME) to further evaluate the safety, efficacy, and immunogenicity of RaniEyes® in real world clinical practice.

Patients with neovascular AMD or DME who provide written informed consent will be screened for this study. Eligible patients will be treated with RaniEyes® 0.5 mg (0.05 mL of 10 mg/mL ranibizumab) intravitreal injection over a period of 6 months. Safety, efficacy, and immunogenicity assessment will be done periodically during the course of the study.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: All

入选标准

•Adult patients (men or women) with confirmed diagnosis of choroidal neovascularization (CNV) secondary to AMD or visual impairment due to DME
•Able to understand the study procedures and the risks involved, willing to provide written Informed Consent, and able to adhere to study schedules and requirements.
•Men and women of childbearing potential must be using adequate birth control measures.

排除标准

•Choroidal neovascularization or visual impairment in the study eye due to causes other than AMD or DME
•Patients receiving other anti-VEGF therapies
•Uncontrolled glaucoma
•Patients with uncontrolled diabetes mellitus
•Intraocular surgery (including cataract surgery) within 2 months in the study eye
•Active intraocular inflammation or ongoing infection in the study eye.
•Patients with active proliferative diabetic retinopathy.
•Patients with vitreous hemorrhage.
•Active or ongoing ocular infection or severe inflammation in either of the eyes.
•Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the study period or that contraindicates the use of ranibizumab.

研究者

发起方

Lupin Limited

申办方类型

Pharmaceutical industry-Indian

责任方

Principal Investigator

主要研究者

Dr Chirag Shah

LUPIN LIMITED

研究点 (6)

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