Non Exudative AMD Imaged With SS-OCT- Extension (BIRC-02)

Boston Image Reading Center (BIRC)

Status: Enrolling

Conditions: Dry Macular Degeneration

Treatments: Device: SS-OCT imaging

Study type: Observational

Funder types: Industry

Identifiers

NCT04469140

BIRC-02 IMPACT SWAGGER

Details and patient eligibility

About

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.

Full 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).

Enrollment: 450 estimated patients

Sex: All

Volunteers: No 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

Trial design

450 participants in 3 patient groups

Cohort 1 'IMPACT Cohort'

Description:

Subjects with intermediate AMD in both eyes, and at least one eye with a drusen volume in the central 3 mm circle centered on the fovea of at least 0.02mm3 in the absence of GA or nGA as diagnosed with OCT en face imaging OR subjects with AMD (early or intermediate) diagnosed in one eye and exudative AMD diagnosed in the fellow eye will undergo SS-OCT imaging every 3 months for 2 years

Treatment:

Device: SS-OCT imaging

Cohort 2 'SWAGGER Cohort'

Description:

Subjects with 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 will undergo SS-OCT imaging every 3 months for 2 years

Treatment:

Device: SS-OCT imaging

Cohort 3

Description:

Subjects with GA enrolled in another trial

Treatment:

Device: SS-OCT imaging