Age-Related Macular Degeneration
Conditions
Keywords
Intermediate AMD, Progression Biomarkers, Late AMD, SD-OCT
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTOrthoptic assessment (Outcome measure)
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).
Sponsors
iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL
Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal
Centro Hospitalar De São João, E.P.E.
Universidade Nova de Lisboa
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
No
Inclusion criteria
* To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered. * Accept and sign the consent.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geographic Atrophy (GA) Growth Rate | 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 incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 | iRORA is measured in μm |
| Change in Drusen morphology from baseline | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 | Drusen classified as Serous, Reticular or both |
| Change in Subfoveal drusen area from baseline | 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 other drusen area from baseline | 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 reflectivity from baseline | 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 | 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 ellipsoid zone disruption from baseline | 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 | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 | Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous |
| Change in hyperreflective foci from baseline | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 | Hyperreflective foci changes classified in a) Yes or b) No |
| Change in hyperreflective foci location (within 500-μm disc area) from baseline | 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 |
| Change in hyperreflective foci association to drusen from baseline | 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 |
| Progression to Moderate Vision Loss | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progression to Advanced AMD according to international classification/grading system | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 | Progression defined as the development of geographic atrophy or choroidal neovascularization detected by OCT imaging using autofluorescence, infrared, and/or angiography modules. |
Countries
Portugal
Contacts
Primary ContactRita Flores, MD
Backup ContactSandra Tenreiro, PhD
Outcome results
None listed