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临床试验/NCT05678517
NCT05678517已完成不适用

Seven-year Outcomes Following Intensive Anti-vascular Endothelial Growth Factor Therapy in Patients With Exudative Age-related Macular Degeneration

Semmelweis University2 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2010年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
47
试验地点
2
主要终点
BCVA

研究概览

简要总结

The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD.

详细描述

This study was conducted at two clinical sites in Budapest, Hungary after the "Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2)" phase-3 multicenter, prospective, randomized, double blind clinical trial (ClinicalTrials.gov ID: NCT00637377).

Patients were treated with intravitreal anti-VEGF injections between 2008 and 2017. During the first 2 years in the framework of the VIEW 2 study, participants were randomized per protocol to intravitreal aflibercept or ranibizumab treatment arms and received injections according to the VIEW 2 study protocol.

This study focused on long-term outcomes that happened after the VIEW 2 study. After finishing the VIEW 2 study, patients returned to daily routine medical care and were followed under regular clinical care in real-life conditions and were treated with predominantly ranibizumab anti-VEGF injections (participants received interventions as part of routine medical care). Treatment was administered as needed according to the judgement of the physician. Retreatment criteria were based on visual acuity, signs of activity on optical coherence tomography (OCT) or indirect slit lamp biomicroscopy. Results at the end of the follow-up (year 7) were retrospectively analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Patients

Patients with AMD

干预措施: Anti-VEGF (Drug)

结局指标

主要结局

BCVA

时间窗: At the end of follow-up (year 7)

Best-corrected visual acuity

Retinal fluid

时间窗: At the end of follow-up (year 7)

Presence or absence of intra- or subretinal fluid on spectral-domain optical coherence tomography (OCT)

Geographic atrophy

时间窗: At the end of follow-up (year 7)

Change in size of geographic atrophy on fundus autofluorescence (FAF)

次要结局

  • Number of injections(Over the course of the follow-up (7 years))
  • Adverse events(Over the course of the follow-up (7 years))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Papp András

Associate Professor

Semmelweis University

研究点 (2)

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