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

Recruiting

• Conditions: Age-Related Macular Degeneration
• Interventions: Diagnostic Test: Orthoptic assessment (Outcome measure)

• Registration Number: NCT06355830
• Lead Sponsor: Universidade Nova de Lisboa

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.

Study Timeline

• Study Start: 2019-01-02
• Study First Submitted: 2023-03-07
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-03
• Last Update Submitted: 2024-04-03
• Study First Posted: 2024-04-09
• Last Update Posted: 2024-04-09
• Primary Completion: 2025-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
intermediate AMD	Orthoptic assessment (Outcome measure)	Subjects over 55 years old with drusen secondary to intermediate AMD

Primary Outcome Measures

Name	Time	Method
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 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 morphology from baseline	Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48	Drusen classified as Serous, Reticular or both
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 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
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 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
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 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 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
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE; 🇵🇹 Lisbon, Portugal