Anatomical and Retinal CHanges Evaluated in Real-life GeographY Atrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 主要终点
- Loss of Best-Corrected Visual Acuity of ≥15 ETDRS Letters
研究概览
简要总结
Geographic atrophy (GA) is an advanced form of dry age-related macular degeneration that leads to progressive and irreversible vision loss. The course of visual decline varies widely among patients, and it is not always clear which anatomical features of the retina are associated with faster loss of vision.
This retrospective observational study aims to describe the natural history of vision loss in patients with geographic atrophy who have characteristics similar to those enrolled in recent clinical trials. The study will analyze previously collected clinical and imaging data from patients followed during routine clinical care at a single center.
The main goal of the study is to evaluate the relationship between changes in visual function and retinal anatomical features, such as the size and location of atrophic lesions and retinal layer integrity, using fundus autofluorescence and optical coherence tomography images.
No treatments or study procedures are performed as part of this research. All data used in the study were collected during standard clinical practice and analyzed retrospectively.
详细描述
This is a monocentric, retrospective observational study designed to evaluate the relationship between visual function and retinal anatomical features in a population with geographic atrophy (GA) secondary to dry age-related macular degeneration.
The study will analyze a natural history cohort identified from previously collected clinical and imaging data obtained during routine care at IRCCS Ospedale San Raffaele. Eligible eyes meet predefined inclusion and exclusion criteria consistent with those used in recent clinical trials, including well-demarcated GA lesions, preserved baseline visual acuity, and the absence of choroidal neovascularization or prior intravitreal treatment.
The primary objective is to estimate the proportion of eyes experiencing a loss of at least 15 ETDRS letters from baseline and to characterize the trajectory of visual acuity decline over time. Secondary objectives include the identification of baseline anatomical features associated with the risk and timing of significant visual loss, such as GA lesion size, foveal involvement, fundus autofluorescence patterns, lesion focality, and outer retinal layer thickness measured on optical coherence tomography.
Exploratory analyses will investigate the relationship between visual function decline and ellipsoid zone integrity metrics, where available, and will apply multivariable and machine learning-based models to explore non-linear associations between anatomical and functional parameters.
As this is a retrospective study, no investigational medicinal products, devices, or study-specific interventions are involved. All analyses are performed on pseudonymized or anonymized data derived from existing medical records and imaging archives. No additional patient contact, visits, or procedures are required.
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
- 否
入选标准
- •Male or female patients aged 50 years or older at baseline.
- •Diagnosis of geographic atrophy secondary to dry age-related macular degeneration in the study eye.
- •Well-demarcated geographic atrophy lesions confirmed by fundus autofluorescence imaging, with a total lesion area between 2.5 mm² and 17.5 mm².
- •Presence of hyperautofluorescence in the junctional zone of the geographic atrophy lesion.
- •Best-corrected visual acuity between 45 and 83 ETDRS letters at baseline.
- •Availability of longitudinal clinical and imaging data with at least 6 months of follow-up.
排除标准
- •Evidence or history of neovascular (wet) age-related macular degeneration in the study eye.
- •Prior intravitreal therapy or systemic treatments specifically targeting age-related macular degeneration.
- •Geographic atrophy lesions contiguous with peripapillary atrophy.
- •Coexisting ocular diseases that could independently affect visual acuity or retinal structure.
- •Incomplete or poor-quality clinical or imaging data precluding reliable assessment of study outcomes.
结局指标
主要结局
Loss of Best-Corrected Visual Acuity of ≥15 ETDRS Letters
时间窗: From baseline to the last available follow-up visit, with a minimum follow-up of 6 months and a preferred follow-up of 12 to 15 months.
Proportion of eyes experiencing a loss of at least 15 ETDRS letters from baseline best-corrected visual acuity. Visual acuity is measured using the ETDRS methodology under normal luminance conditions, based on clinical data collected during routine care.
次要结局
未报告次要终点
研究者
Maria Vittoria Cicinelli
Principal Investigator
IRCCS Ospedale San Raffaele