NCT06355830

Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Universidade Nova de Lisboa · Academic / Other
• Sex: All
• Age: 55 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Age-Related Macular Degeneration

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Orthoptic 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).

Timeline

• Start date: 2019-01-02
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-04-09
• Last updated: 2024-04-09

Locations

1 site across 1 country: Portugal