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

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.

Study Overview

• Status: Recruiting
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Diagnostic test: Orthoptic assessment (Outcome measure)

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 Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

• Study Contact: Name: Rita Flores, MD; Phone Number: 21355 00351218841000; Email: ritamariaflores@gmail.com
• Study Contact Backup: Name: Sandra Tenreiro, PhD; Phone Number: 26025 00351218803100; Email: stenreiro@nms.unl.pt

Study Locations

• Portugal
  • Lisbon, Portugal, 1150-199
    • Recruiting
    • Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE
    • Contact: Rita Flores, MD; Phone Number: 21355 00351218841000; Email: ritamariaflores@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects over 55 years old with drusen secondary to intermediate AMD

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intermediate AMD; Subjects over 55 years old with drusen secondary to intermediate AMD	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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
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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Universidade Nova de Lisboa
• Collaborators: iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL; Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal; Centro Hospitalar Universitário de São João, Porto, Portugal
• Investigators: Principal Investigator: Rita Flores, MD, Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa; Study Chair: Sandra Tenreiro, PhD, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: March 7, 2023
• First Submitted That Met QC Criteria: April 3, 2024
• First Posted (Actual): April 9, 2024

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: SD-OCT; Intermediate AMD; Progression Biomarkers; Late AMD
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: RETimaging4iAMD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No