A Collaborative Resource of Heidelberg Multimodal Imaging of Intermediate and Early Atrophic AMD Cases to Study Prediction of Disease Progression: (INTERCEPT-AMD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 42
- 主要终点
- Incidence of conversion to atrophy at two years
研究概览
简要总结
This is a multicentre retrospective and prospective cohort study with the goal to develop a well-characterised multimodal image database of eyes with intermediate AMD with and without early atrophy. The main objectives are:
- Develop a collaborative well-characterised database on intermediate AMD with or without early atrophy.
- Grading of these images to explore imaging markers of progression.
- Develop predictive models as a secondary analysis of our dataset.
This study will recruit around 1.000 eyes in 6 months. All consenting patients who have had at least 3 clinic visits with multimodal imaging done at least at 6 months interval between 2 visits and meet the inclusion and exclusion criteria will be included in the study for retrospective data collection. Those with one visit remaining to complete 2 years, images will be acquired prospectively. In addition to the images, routine demographic data (age and sex) and available visual acuity (VA) (BCVA if possible, VA with Pinhole or VA with patient's glasses) will be collected. Multimodal imaging includes mandated macular OCT with or without enhanced depth imaging and infrared imaging. Fundus autofluorescence (AF) and multicolor imaging are optional. All imaging must be done on Heidelberg Spectralis system.
详细描述
Age-related macular degeneration (AMD) is the commonest cause of visual impairment in older people in Europe. It is a slowly progressing complex disorder. The clinical progression is best described as early, intermediate, and advanced based on the latest classification system on colour fundus photographs. However, multimodal imaging has enabled visualisation of further changes in the retina on optical coherence tomography (OCT), infrared imaging, and autofluorescence. So, a large database of imaging data of intermediate AMD will facilitate researchers to study the disease progression in detail. This study is a collaborative effort by investigators across many Member Sites in Europe that are members of EVICR.net to pool datasets for secondary analysis.
EVICR.net is a network of Ophthalmological Clinical Research Sites, dedicated to performing multinational clinical research in ophthalmology with the highest standards of quality, following the European and International Directives for Clinical Research in order to strengthen the capacity of the European Union to study the determinants of ophthalmic diseases and to develop and optimise the use of diagnostic, prevention and treatment strategies in ophthalmology.
EVICR.net Eye Platform is a long-term initiative to establish a platform to gather high quality ophthalmology data generated in Europe and allow the secondary use of data in performing large data analysis and foster clinical research.
With this Eye Platform EVICR.net aims to provide technological solutions that allow overcoming privacy and regulation issues associated with the sharing of data from different institutions/countries, in a secure, easy to use manner.
With EVICR.net Eye Platform, the Members Sites will have the opportunity to participate in clinical research with secondary use data analysis; Authorship of publications and presentations of Results; the opportunity to propose new analysis to answer key research questions; and increase overall visibility and stature as researchers
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each dataset per patient should have one eye as the study eye with:
- •Intermediate AMD with no atrophy and no subretinal drusenoid deposits
- •Intermediate AMD with no atrophy with subretinal drusenoid deposits
- •Intermediate AMD with early atrophy (iRORA) with no Subretinal drusenoid deposits
- •Intermediate AMD with early atrophy (iRORA) with Subretinal drusenoid deposits
- •Intermediate AMD with evidence of cRORA
- •Non-study eye images will not be exported but information about the status of the macula should be added using the following options:
- •Established Geographic Atrophy (cRORA)
- •Exudative AMD (presence of MNV)
- •Early AMD
- •Healthy macula
排除标准
- •Both eyes have exudative AMD or geographic atrophy at baseline.
- •Co-existent ocular disease: Any other ocular condition that, in the investigator's opinion, might affect or alter visual acuity during the study.
- •Any patient who has opted out of their information being used for research nationally or locally at any Member Site.
结局指标
主要结局
Incidence of conversion to atrophy at two years
时间窗: 24 months
Number of patients who developed new or increasing atrophy
次要结局
未报告次要终点