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| Name | Class |
|---|---|
| iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL | UNKNOWN |
| Centro Hospitalar de Lisboa Central | OTHER |
| Centro Hospitalar De São João, E.P.E. | OTHER |
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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
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:
2.1. Analyze superficial retinal capillary plexus (SCP), 2.2. Analyze deep retinal capillary plexus (DCP);
Assess if choroidal and retinal vascular changes are related to disease progression.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| intermediate AMD | Subjects over 55 years old with drusen secondary to intermediate AMD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Orthoptic assessment (Outcome measure) | Diagnostic Test | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) from baseline | iRORA is measured in μm | 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 | 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 | 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 | 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 | 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 | 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 | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects over 55 years old with drusen secondary to intermediate AMD
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rita Flores, MD | Contact | 00351218841000 | 21355 | ritamariaflores@gmail.com |
| Sandra Tenreiro, PhD | Contact | 00351218803100 | 26025 | stenreiro@nms.unl.pt |
| Name | Affiliation | Role |
|---|---|---|
| Rita Flores, MD | Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa | Principal Investigator |
| Sandra Tenreiro, PhD | iNOVA4Health Nova Medical School, Universidade Nova de Lisboa |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE | Recruiting | Lisbon | 1150-199 | Portugal |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Change in Drusen homogeneity from baseline | Drusen homogeneity classified as a) Homogeneous or b) Heterogeneous | 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 | 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 | 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 | 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. | 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 | Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48 |