NCT06355830|Unknown
Intermediate Age-related Macular Degeneration - Multimodal Analysis and Longitudinal Study
Imaging4iAMD
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Imaging4iAMD
Sponsor study identifier
observational
150
1 country
1
Study Start
January 2, 2019
Actual (reported)Primary Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 2, 2019
Actual (reported)March 7, 2023
Actual (reported)April 9, 2024
Actual (reported)June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Progression to Advanced AMD according to international classification/grading system
Months 0 (baseline), 6, 12, 18, 24, 30, 36, 42 and 48
Subjects over 55 years old with drusen secondary to intermediate AMD
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).
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Subjects over 55 years old with drusen secondary to intermediate AMD
Ophthalmology Service, Centro Hospitalar de Lisboa Central EPE
Lisbon, 1150-199, Portugal
Rita Flores, MD
Centro Hospitalar Universitário de Lisboa Central, iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
Sandra Tenreiro, PhD
iNOVA4Health Nova Medical School, Universidade Nova de Lisboa
First Submitted
March 7, 2023
First Posted
April 9, 2024
Study Start
January 2, 2019
Actual (reported)Primary Completion
June 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Effect of Oral Curcumin Supplementation in Dry Age-related Macular Degeneration (AMD) Patients
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
Contact the study team to confirm eligibility.
Study Completion
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
April 9, 2024
Record last verified: 2024-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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