AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study (A2ASDOCT)

Duke University

Status

Completed

Conditions

Age Related Macular Degeneration

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT00734487

Genentech FVF4400

Pro00001749

Details and patient eligibility

About

The purpose of this study is to identify whether changes in age-related macular degeneration (AMD) over time as seen with spectral domain optical coherence tomography (SDOCT) imaging, can be used to predict vision loss and the advancement of AMD in people at moderate to high risk for progression.

Full description

The primary objective of this study is to identify whether SDOCT patterns such as: drusen size, OCT reflectivity within drusen, photoreceptor (PR)change over drusen, microfoci of subretinal fluid (SRF), or retinal thickening are predictive of vision loss, progression of drusen, progression of photoreceptor loss over drusen, development of choroidal neovascularization (CNV), or development of geographic atrophy (GA).

The secondary objectives of this study are:

To define the relationship between SDOCT imaging, autofluorescence (AF)imaging, and color photographic or other fundus imaging of AREDS 2 patients in both a cross-sectional study of baseline data and a longitudinal study in data collected over the 5 year AREDS 2 study.
To compare the extent of geographic atrophy on SDOCT versus color photographs and autofluorescence.
To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2.

Enrollment

470 patients

Sex

All

Ages

50 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

AMD subjects and controls

Men and women between the ages of 50 and 85 years

AMD subjects

Enrollment in the AREDS 2 trial;
Macular status ranges from large drusen in both eyes or large drusen in one eye and advanced AMD (neovascular AMD or geographic atrophy) in the fellow eye

Exclusion criteria