Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change in hyperreflective foci from baseline
研究概览
简要总结
Study: observational prospective clinical study. Study population: Subjects over 55 years old with drusen secondary to intermediate AMD.
Recruitment: at the Medical Retinal Consultation from the Ophthalmology Department of CHULC.
Primary outcome: Identifying imaging predictors of iAMD progression.
详细描述
Individuals will be included consecutively and undergo retinal imaging including Color Fundus photography (CFP), Spectral Domain Optical Coherence Tomography (SD-OCT), OCT-Angiography (OCT-A) using Spectralis OCT, with OCT Angiography Module (Heidelberg Eng. GmbH, Germany), in order to characterize:
A. FUNDUS AUTOFLUORESCENCE
- Analyse the correlation between drusen morphology and autofluorescent findings
- Analyse the correlation between outer retinal layers morphology and autofluorescent findings
- Assess anatomic biomarkers of disease progression
B. VASCULAR FINDINGS
- Test if choriocapillaris perfusion is disturbed in Intermediate AMD patients;
- Test if retinal capillary plexus perfusion is disturbed in Intermediate AMD patients:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered.
- •Accept and sign the consent.
排除标准
- •Patients are excluded if it is not possible to obtain good quality CFP, SD-OCT, OCT-A images, if refractive error is ≥±6D or if there is any evidence of accumulation of extracellular fluid, haemorrhage, exudates or fibrosis.
- •Additional exclusion criteria included any history of retinal surgery including laser treatment, signs of diabetic retinopathy, history of retinal vascular occlusion, history of anti-VEGF treatment in the study eye or any signs or history of hereditary retinal or macular dystrophy.
结局指标
主要结局
Change in hyperreflective foci from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Hyperreflective foci changes classified in a) Yes or b) No
Change in other drusen area from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Other drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Change in Drusen morphology from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen classified as Serous, Reticular or both
Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
iRORA is measured in μm
Change in hyperreflective foci association to drusen from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
hyperreflective foci association to drusen from baseline classified as a) Yes or b) No
Change in Drusen reflectivity from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen reflectivity classified as a) Low, b) Intermediate, c) High
Change in other Drusen homogeneity from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen homogeneity classified in a) Low b) Intermediate or c) High
Change in hyperreflective foci location (within 500-μm disc area) from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
hyperreflective foci location (within 500-μm disc area) changes classified as a) Yes or b) No
Geographic Atrophy (GA) Growth Rate
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
The annual growth rate of GA or nascent GA area measured in square root transform of the area measured in mm2 (final values in mm), based on SD-OCT Spectralis Heidelberg
Change in Subfoveal drusen area from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Subfoveal drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Change in ellipsoid zone disruption from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
ellipsoid zone disruption changes classified in a) Yes or b) No
Change in Drusen homogeneity from baseline
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous
Progression to Moderate Vision Loss
时间窗: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
次要结局
- Progression to Advanced AMD according to international classification/grading system(Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48)