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

Status: Unknown
Location: See all (5) locations...
Intervention Type: Device
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• Aged 50 and over

• 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

Locations
United States
California
University of California Los Angeles Doheny Eye Institute
Los Angeles
Florida
Bascom Palmer Eye Institue
Miami
Massachusetts
New England Eye Center/Tufts Medical Center
Boston
New York
Vitreous Retina Macular Consultants of NY
New York
Other Locations
Australia
Melbourne University CERA
East Melbourne
Time Frame
Start Date: 2018-01-18
Completion Date: 2023-03
Participants
Target number of participants: 225
Treatments
Cohort 1 'IMPACT Cohort'
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
Cohort 2 'SWAGGER Cohort'
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
Cohort 3
Subjects with GA enrolled in another trial
Sponsors
Leads: Boston Image Reading Center

This content was sourced from clinicaltrials.gov

Similar Clinical Trials