IMPACT/SWAGGER

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

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Macular degeneration
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All genders
person-wave 50+
world
Recruiting now

Overview
Principal Investigator: Michelle Liang, MD

This is a longitudinal observational study that will look at 300 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 100 subjects with nGA or GA in at least one eye.

The target population is all subjects who are at least 50 years of age and have a clinical diagnosis of non-exudative AMD in at least one eye.

Subjects who convert to exudative AMD during the study will be treated as per the enrolling physician’s standard of care and will continue to be scanned per protocol, allowing for a wider interval of +/- 30 days around the standard timing of scanning to avoid excessively frequent visits.

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Michael Dixon

Study details
Inclusion Criteria
  • 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
  • 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
  • Clinical diagnosis of GA or nGA secondary to AMD that is at least the size of a large drusen (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
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
Study Requirements

At baseline, subjects will receive visual acuity testing, low luminance acuity testing, a complete ophthalmological exam, color fundus photos, fundus autofluorescence imaging, infrared reflectance imaging, and OCT imaging with SS-OCTA. Subjects will be followed with OCTA at 3-month intervals for a total of 2 years. All other imaging will be performed at baseline and at months 12 and 24

All subjects will also receive optional genetic testing to correlate to their exam findings and disease progression.