RECRUITING

Non Exudative AMD Imaged With SS-OCT- Extension

Conditions

Dry Macular Degeneration AMD Early AMD Intermediate AMD Geographic Atrophy Nascent GA

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2020-01-18

Study Completion:2025-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04469140

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Jen Tourtellot

CONTACT

1-855-535-BIRC (2472)

admin@bostonimagereadingcenter.com

Principal Investigator

Nadia Waheed, MD

PRINCIPAL_INVESTIGATOR

Boston Image Reading Center/Tufts Medical Center

Philip Rosenfield, MD, PhD

PRINCIPAL_INVESTIGATOR

Bascom Palmer Eye Institute

Study Locations (Sites)

University of California Los Angeles Doheny Eye Institute

Los Angeles, California, 91105

United States

Bascom Palmer Eye Institue

Miami, Florida, 33136

United States

New England Eye Center/Tufts Medical Center

Boston, Massachusetts, 02111

United States

Vitreous Retina Macular Consultants of NY

New York, New York, 10022

United States

Collaborators and Investigators

Sponsor: Boston Image Reading Center

Nadia Waheed, MD, PRINCIPAL_INVESTIGATOR, Boston Image Reading Center/Tufts Medical Center
Philip Rosenfield, MD, PhD, PRINCIPAL_INVESTIGATOR, Bascom Palmer Eye Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-18

Study Completion Date2025-08

Study Record Updates

Study Start Date2020-01-18

Study Completion Date2025-08

Terms related to this study

Keywords Provided by Researchers

AMD
Early AMD
Intermediate AMD
Geographic Atrophy
Nascent GA

Additional Relevant MeSH Terms

Dry Macular Degeneration