Non Exudative AMD Imaged With SS-OCT- Extension

  • STATUS
    Recruiting
  • participants needed
    450
  • sponsor
    Boston Image Reading Center
Updated on 19 February 2024
age-related macular degeneration
retinal pigment
drug trials
macular degeneration
maculopathy

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.

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. This is an extension of a currently ongoing longitudinal observational study (BIRC-01) (NCT03688243).

Details
Condition Dry Macular Degeneration, age-related macular degeneration, macular degeneration, macular degeneration
Age 100years or below
Treatment SS-OCT imaging
Clinical Study IdentifierNCT04469140
SponsorBoston Image Reading Center
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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