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UNKNOWN

Non Exudative AMD Imaged With SS-OCT

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography

NCT03688243•Boston Image Reading Center

Summary

The investigators wish to better understand the role of the choriocapillaris (CC) in the formation and progression of non-exudative in age related macular degeneration (armd) by imaging the retinal pigment epithelium (rpe) and the choroidal microvasculature and by studying their inter-dependence to determine if the loss of the CC could prove useful as an anatomic clinical trial endpoint in future drug trials.

Detailed Description

This is a longitudinal observational study where the investigators will look at 450 subjects, 200 with intermediate AMD in at least one eye, or with AMD in one eye, either early or intermediate, and with late AMD (exudative) in the other eye, and 250 subjects with nGA or GA in at least one eye.

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged 50 and over
•2. Clinic diagnosis of non-exudative iAMD in at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02 mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR Clinical diagnosis of early or early/intermediate stage AMD in one eye in the absence of nGA or GA and exudative AMD in the other eye OR clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large druse (125 microns in diameter; 0.05 mm2) and no greater than 7 disc areas (17 mm2) in at least one eye which has never been treated with anti-VEGF agents
•3. Willing and able to comply with clinic visits and study-related procedures
•4. Provide signed informed consent

Exclusion Criteria

•A subject who meets any of the following criteria will be excluded from the study:
•1. Below the age of 50
•2. Subjects with exudative AMD in both eyes
•3. Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.
•4. Presence of confounding ocular diagnosis such as myopia \>6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV
•5. Subjects unable to give informed consent.
•6. Subjects who are unable to comply with imaging guidelines

Locations (5)

University of California Los Angeles Doheny Eye Institute

Los Angeles, California, United States

Bascom Palmer Eye Institue

Miami, Florida, United States

New England Eye Center/Tufts Medical Center

Boston, Massachusetts, United States

Vitreous Retina Macular Consultants of NY

New York, New York, United States

Melbourne University CERA

East Melbourne, Victoria, Australia

Key Dates

Start Date

January 18, 2018

Primary Completion Date

March 1, 2023

Completion Date

March 1, 2023

Last Updated

March 10, 2022

Enrollment

225

ACTUAL participants

Conditions

Dry Macular Degeneration

Interventions

SS-OCT imaging

DEVICE

Alpha MSH in Ocular Disease

NCT03451578

Advanced Dry Macular Degeneration

View study

UNKNOWN

Non Exudative AMD Imaged With SS-OCT- Extension

NCT04469140

Dry Macular Degeneration

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 10, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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