Age Related Macular Degeneration, Geographic Atrophy
Conditions
Keywords
Age Related Macular Degeneration, Geographic Atrophy, Imaging, OCT
Brief summary
The objective of this study is to compare Cirrus HD-OCT automated measurements of the illumination area under the retinal pigment epithelium (RPE) to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images.
Detailed description
Specific Objectives: 1. To compare Cirrus HD-OCT automated measurements of the illumination area under the RPE to expert manual measurements of areas of hypofluorescence typical of geographic atrophy in fundus autofluorescence (FAF) images. 2. To describe the differences and similarities between Cirrus HD-OCT and fundus autofluorescence images of subjects with geographic atrophy secondary to dry age-related macular degeneration (AMD). 3. To determine the clinical factors that affect the Cirrus HD-OCT automated measurements of the illumination area under the RPE.
Interventions
None listed
Sponsors
Carl Zeiss Meditec, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy. * Geographic atrophy lesions should: * Not be greater than 5 mm at the widest diameter. The entire lesion(s) should fit into the 6x6 mm scan area of the Cirrus HD-OCT. * Not be smaller than 1.25 mm2. * Not be confluent with peri-papillary atrophy. * Not be combined with other lesions such as CNVs. * Able and willing to make the required study visit. * Able and willing to give consent and follow study instructions.
Exclusion criteria
* History of retinal surgery, laser photocoagulation, and/or radiation therapy to the eye. * Evidence of other retinal diseases of the eye, including wet AMD, diabetic retinopathy, diabetic macular edema, or significant vitreomacular traction upon dilated examination, or upon evaluation of retinal photos. * Thick media opacity or inability to fixate that precludes obtaining acceptable scans. * Concomitant use of hydrochloroquine and chloroquine. * Unable to make the required study visit. * Unable to give consent or follow study instructions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA). | August 2011 | In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists. |
Countries
United States
Participant flow
Recruitment details
85 subjects were enrolled between 1/10/2011 - 2/25/2011. The study was conducted at Retina Specialist clinics.
Pre-assignment details
After enrollment a screening image of the retina is done to ensure that the area of Geographic Atrophy is consistent with the inclusion criteria. We enrolled 85 subjects, however, 19 were determined not to be eligible per study protocol. In addition, images of 14 subjects did not meet predetermined qualification criteria per study protocol.
Participants by arm
| Arm | Count |
|---|---|
| GA Group Patients diagnosed with dry AMD and geographic atrophy | 52 |
| Total | 52 |
Baseline characteristics
| Characteristic | GA Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 50 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants |
| Age, Continuous | 83.6 years STANDARD_DEVIATION 6.2 |
| Region of Enrollment United States | 52 participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 52 |
| serious Total, serious adverse events | 0 / 52 |
Outcome results
Primary
Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).
In retinal areas with atrophy, light emitted from the Cirrus penetrates the sclera and choroid which are more reflecting compared with the Retinal Pigment Epithelium (RPE). The areas with higher illumination are associated with areas of Geographic Atrophy (GA), and allow to quantify how big is the area of atrophy. The study will assess the difference between Cirrus HD-OCT measurements of areas of increased illumination under the RPE to hypofluorescence areas on fundus photos as assessed manually by retina specialists.
Time frame: August 2011
Population: Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| GA Group | Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA). | 0.1 mm^2 | Standard Deviation 1.9 |