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临床试验/NCT01256827
NCT01256827已完成不适用

Seven Year Observational Update of Macular Degeneration Patients Post-MARINA/ANCHOR and HORIZON Trials (SEVEN UP Study)

University of California, San Francisco12 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
65
试验地点
12
主要终点
visual acuity 20/70 or better

研究概览

简要总结

The purpose is to assess long term vision outcomes and disease status in patients with age-related macular degeneration previously treated with ranibizumab as participants in the Phase 3 ANCHOR and MARINA Studies and the HORIZON Study.

详细描述

This is a cross-sectional cohort study of exudative age-related macular degeneration (AMD) patients seven or more years after initiation of the intravitreal ranibizumab regimen in the treatment arms of the pivotal ANCHOR or MARINA studies, who had subsequent follow up in the HORIZON Study. While the MARINA and ANCHOR studies established the benefit of ranibizumab at 2 years, many patients in the U.S. have now undergone treatment for many years, and the longer-term outcomes for this chronic disease remain unknown. Despite earlier hopes for limited duration treatment, subsequent clinical experience suggests that many patients require continued treatment. The patient population for this study is unique, in that the patients in the treatment arms of MARINA and ANCHOR are some of the earliest treated patients, providing the longest-term data available for AMD patients receiving ranibizumab. Patients recalled into this study will be evaluated to provide an update on their current visual acuity, disease activity status, anatomic characteristics, and genotype. There is a single study visit to extend the clinical history and to perform vision testing, ophthalmologic examination, and retinal imaging studies, including high-resolution spectral-domain OCT and fundus autofluorescence imaging, technologies unavailable at the time of the original ANCHOR and MARINA Trials. Genetic analysis will be performed for known AMD risk genes as well as candidate genes to study genotypic profiles associated with AMD disease progression and long-term treatment response. Understanding the course of 7-plus years of current generation AMD treatment will serve physicians in the ongoing management of this chronic disease.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

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

入选标准

  • previous participants in the ANCHOR or MARINA studies, and...
  • who were assigned to one of the ranibizumab treatment arms, and...
  • who were enrolled in the HORIZON extension study with a current SEVEN UP investigator
  • ability to provide written informed consent and comply with study assessments

排除标准

  • any separate ophthalmologic condition that the investigator believes would interfere with anatomic assessments in the trial

结局指标

主要结局

visual acuity 20/70 or better

时间窗: at date of study visit

percentage of study eyes with vision of 20/70 or better (ETDRS best-corrected vision with Snellen equivalent)

次要结局

  • central geographic atrophy(date of study visit)
  • mean change in visual acuity(at study visit)
  • visual acuity 20/40 or better(at date of study visit)
  • visual acuity 20/200 or worse(at date of study visit)
  • exudative AMD disease quiescence(at date of study visit and 6 months prior history)
  • genotypic profile(date of study visit)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (12)

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