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UNKNOWN

Non Exudative AMD Imaged With SS-OCT- Extension

Non Exudative Age-Related Macular Degeneration Imaged With Swept Source Optical Coherence Tomography: The Extension Study

NCT04469140•Boston Image Reading Center

View on ClinicalTrials.gov

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

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Enrollment in and completion of the BIRC-01 study
•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
•Willing and able to comply with clinic visits and study-related procedures
•Provide signed informed consent

Exclusion Criteria

•Subjects with exudative AMD in both eyes
•Eyes with evidence of non-proliferative and proliferative diabetic retinopathy.
•Presence of confounding ocular diagnosis such as myopia \>6D, or other ocular conditions that may cause retinal pigment epithelium atrophy or exudative MNV
•Subjects currently or previously enrolled in other interventional clinical trials in which treatment was administered to the study eye.
•Previous vitrectomy or intravitreal injections in the study eye.
•Axial length measurement ≥ 26 mm.
•Subjects unable to give informed consent.
•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, 2020

Primary Completion Date

August 1, 2025

Completion Date

August 1, 2025

Last Updated

March 10, 2022

Enrollment

450

ESTIMATED participants

Conditions

Dry Macular Degeneration

Interventions

SS-OCT imaging

DEVICE

Contacts

Jen Tourtellot

CONTACT

1-855-535-BIRC (2472)admin@bostonimagereadingcenter.com

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UNKNOWN

Non Exudative AMD Imaged With SS-OCT

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Dry Macular Degeneration

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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.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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