A2ASDOCT: AREDS 2 Ancillary Spectral Domain Optical Coherence Tomography Study

Sponsor

Duke University (Other)

Overall Status

Completed

CT.gov ID

NCT00734487

Collaborator

Genentech, Inc. (Industry)

470

Enrollment

Locations

Duration (Months)

117.5

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Age Related Macular Degeneration

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

470 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Age-Related Eye Disease Study 2 Ancillary Spectral Domain Optical Coherence Tomography Study

Study Start Date :

Jun 1, 2008

Actual Primary Completion Date :

Aug 1, 2015

Actual Study Completion Date :

Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
1. AREDS2 subjects Subjects enrolled in the AREDS2 clinical trial with a diagnosis of age-related macular degeneration.
2. Controls Age-matched subjects without retinal pathology

Outcome Measures

Primary Outcome Measures

Primary outcome measures are the percent of eyes developing CNV, mean change in visual acuity, and change in drusen volume, area of GA and photoreceptor layer thickness from SDOCT centered on the fovea. [2 years and 5 years]

Secondary Outcome Measures

Drusen area measured from SDOCT versus from color fundus photographs. Mean change in drusen area reproducibility of measurements using these techniques. [2 years and 5 years]
Grading of drusen type, presence or absence of fluid, photoreceptor loss or retinal thickening from SDOCT versus from color fundus photographs at each timepoint. [2 years and 5 years]
Correlation between SDOCT imaging and autofluorescence imaging and onset of geographic atrophy. [2 years and 5 years]
Measurement of area of GA from SDOCT images versus color fundus photos versus AF images. [2 years and 5 years]
To evaluate whether the SDOCT outcome measures differ significantly between AREDS 2 patients randomized to different oral supplements in the AREDS2. [5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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:

Ocular media not clear enough to allow good fundus photography.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University Eye Center	Atlanta	Georgia	United States	30322
2	National Eye Institute	Bethesda	Maryland	United States	20892
3	Duke University Eye Center	Durham	North Carolina	United States	27705
4	Devers Eye Center	Portland	Oregon	United States	97210