A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea High Dose (HD) in Participants with Diabetic Macular Edema (ALVOEYE-HD).

Alvotech Swiss AG10 个研究点分布在 1 个国家目标入组 256 人开始时间: 2026年4月29日最近更新: 2026年4月1日

试验速览

阶段: 3 期
状态: 尚未招募
发起方: Alvotech Swiss AG
入组人数: 256
试验地点: 10

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

This is a randomized, double-masked, parallel-group, active-controlled, multicenter Phase 3 study evaluating the efficacy, safety, and immunogenicity of AVT29 (a proposed aflibercept 8 mg biosimilar) compared with Eylea HD in participants with Diabetic Macular Edema (DME). The study aims to demonstrate equivalent clinical efficacy and comparable safety and immunogenicity between AVT29 and the reference product.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Double

入排标准

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

入选标准

•As specified in Protocol Section 4.2 and 4.3 (Inclusion and Exclusion Criteria).

排除标准

•As specified in Protocol Section 4.2 and 4.3 (Inclusion and Exclusion Criteria).

研究者

发起方

Alvotech Swiss AG

申办方类型

Pharmaceutical industry-Global

责任方

Principal Investigator

主要研究者

Dr Rohan Chauhan

Rising Retina Clinic

研究点 (10)

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