Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study (Imaging4iAMD)

New University of Lisbon

Status: Enrolling

Conditions: Age-Related Macular Degeneration

Treatments: Diagnostic Test: Orthoptic assessment (Outcome measure)

Study type: Observational

Funder types: Other

Identifiers

NCT06355830

RETimaging4iAMD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 estimated patients

Sex: All

Ages: 55 to 95 years old

Volunteers: No Healthy Volunteers

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 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.

Trial design

150 participants in 1 patient group

intermediate AMD

Description:

Subjects over 55 years old with drusen secondary to intermediate AMD

Treatment:

Diagnostic Test: Orthoptic assessment (Outcome measure)