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

NCT06355830 | Recruiting

• 1 other identifier: RETimaging4iAMD
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Age-Related Macular Degeneration

Keywords

Intermediate AMD; Progression Biomarkers; Late AMD; SD-OCT

Outcome Measures

Primary Outcomes (13)

• 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 Outcomes (1)

• Progression to Advanced AMD according to international classification/grading system

  Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48

Study Arms (1)

intermediate AMD

Subjects over 55 years old with drusen secondary to intermediate AMD

Diagnostic Test: Orthoptic assessment (Outcome measure)

Interventions

Orthoptic assessment (Outcome measure) DIAGNOSTIC_TEST

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).

intermediate AMD

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects over 55 years old with drusen secondary to intermediate AMD

You may qualify if:

• To verify the existence of drusen secondary to intermediate AMD; Soft, cuticular and reticular pseudo-drusen will be considered.
• Accept and sign the consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Nova de Lisboa: lead
• iNOVA4Health, NOVA Medical School|Faculdade de Ciências Médicas, NMS|FCM, UNL: collaborator
• Centro Hospitalar de Lisboa Central EPE, Lisboa, Portugal: collaborator
• Centro Hospitalar De São João, E.P.E.: collaborator

Study Sites (1)

Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE

Lisbon, 1150-199, Portugal

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Rita Flores, MD

  Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa

  PRINCIPAL INVESTIGATOR

• Sandra Tenreiro, PhD

  iNOVA4Health Nova Medical School, Universidade Nova de Lisboa

  STUDY CHAIR

Central Study Contacts

Rita Flores, MD

CONTACT

00351218841000; ritamariaflores@gmail.com

Sandra Tenreiro, PhD

CONTACT

00351218803100; stenreiro@nms.unl.pt

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2023
• First Posted: April 9, 2024
• Study Start: January 2, 2019
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)