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

Age-Related Macular Degeneration Clinical Trial

— Imaging4iAMD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06355830
• Other study ID #: RETimaging4iAMD
• Status: Recruiting
• Start date: January 2, 2019
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: Universidade Nova de Lisboa
• Contact: Rita Flores, MD
• Phone: 00351218841000
• Email: ritamariaflores[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2026
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

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).

Locations

Country	Name	City	State
Portugal	Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE	Lisbon

Sponsors (4)

Lead Sponsor	Collaborator
Universidade Nova de Lisboa	Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal, Centro Hospitalar Universitário de São João, Porto, Portugal, iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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