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.
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 1. Analyse the correlation between drusen morphology and autofluorescent findings 2. Analyse the correlation between outer retinal layers morphology and autofluorescent findings 3. Assess anatomic biomarkers of disease progression B. VASCULAR FINDINGS 1. Test if choriocapillaris perfusion is disturbed in Intermediate AMD patients; 2. Test if retinal capillary plexus perfusion is disturbed in Intermediate AMD patients: 2.1. Analyze superficial retinal capillary plexus (SCP), 2.2. Analyze deep retinal capillary plexus (DCP); 3. Assess if choroidal and retinal vascular changes are related to disease progression.
Study Type
OBSERVATIONAL
Enrollment
150
The protocol image assessment is non-invasive and includes retinal imaging by 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).
Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE
Lisbon, Portugal
RECRUITINGChange in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline
iRORA is measured in μm
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Drusen morphology from baseline
Drusen classified as Serous, Reticular or both
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Subfoveal drusen area from baseline
Subfoveal drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in other drusen area from baseline
Other drusen area is measured in μm2, based on SD-OCT Spectralis Heidelberg
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Drusen reflectivity from baseline
Drusen reflectivity classified as a) Low, b) Intermediate, c) High
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in other Drusen homogeneity from baseline
Drusen homogeneity classified in a) Low b) Intermediate or c) High
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in ellipsoid zone disruption from baseline
ellipsoid zone disruption changes classified in a) Yes or b) No
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in Drusen homogeneity from baseline
Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous
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Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in hyperreflective foci from baseline
Hyperreflective foci changes classified in a) Yes or b) No
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in hyperreflective foci location (within 500-μm disc area) from baseline
hyperreflective foci location (within 500-μm disc area) changes classified as a) Yes or b) No
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Change in hyperreflective foci association to drusen from baseline
hyperreflective foci association to drusen from baseline classified as a) Yes or b) No
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Progression to Moderate Vision Loss
Progression defined as a decrease in ETDRS BCVA score of 15 or more letters.
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Geographic Atrophy (GA) Growth Rate
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
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Progression to Advanced AMD according to international classification/grading system
Progression defined as the development of geographic atrophy or choroidal neovascularization detected by OCT imaging using autofluorescence, infrared, and/or angiography modules.
Time frame: Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48