Non Exudative AMD Imaged With SS-OCT- Extension

Status unconfirmed

Conditions studied: Dry Macular Degeneration

In brief

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.

Key facts

Study ID

NCT04469140

Run by

Boston Image Reading Center

People needed

450

Starts

2020-01-18

Expected to finish

2025-08-01

Last updated by the study team

2022-03-10

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of California Los Angeles Doheny Eye Institute — Los Angeles, California, United States (enrolling)
• Bascom Palmer Eye Institue — Miami, Florida, United States (enrolling)
• New England Eye Center/Tufts Medical Center — Boston, Massachusetts, United States (enrolling)
• Vitreous Retina Macular Consultants of NY — New York, New York, United States (enrolling)
• Melbourne University CERA — East Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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