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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.
Specific Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dry AMD and geographic atrophy | Patients diagnosed with dry AMD and geographic atrophy |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | August 2011 |
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Inclusion Criteria:
Males or females 50 years of age and older diagnosed to have advanced dry AMD with geographic atrophy.
Geographic atrophy lesions should:
Able and willing to make the required study visit.
Able and willing to give consent and follow study instructions.
Exclusion Criteria:
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Primary Care Clinic
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| Name | Affiliation | Role |
|---|---|---|
| Carmelina M Gordon, MD | TLC Eye Care and Laser Center | Principal Investigator |
| Eugene S Lit, M.D. | East Bay Retina Consultants | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East Bay Retina Consultants, Inc. | Oakland | California | 94609 | United States | ||
| TLC Eyecare and Laser Centers |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19171212 | Background | Schmitz-Valckenberg S, Fleckenstein M, Scholl HP, Holz FG. Fundus autofluorescence and progression of age-related macular degeneration. Surv Ophthalmol. 2009 Jan-Feb;54(1):96-117. doi: 10.1016/j.survophthal.2008.10.004. | |
| 17239336 | Background | Holz FG, Bindewald-Wittich A, Fleckenstein M, Dreyhaupt J, Scholl HP, Schmitz-Valckenberg S; FAM-Study Group. Progression of geographic atrophy and impact of fundus autofluorescence patterns in age-related macular degeneration. Am J Ophthalmol. 2007 Mar;143(3):463-72. doi: 10.1016/j.ajo.2006.11.041. Epub 2006 Dec 22. |
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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.
85 subjects were enrolled between 1/10/2011 - 2/25/2011. The study was conducted at Retina Specialist clinics.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dry AMD With Geographic Atrophy | Patients diagnosed with dry AMD and geographic atrophy |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | GA Group | Patients diagnosed with dry AMD and geographic atrophy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Subjects with dry AMD and Geographic Atrophy. The required sample size was calculated based on previous experience with the device and its variability. | Posted | Mean | Standard Deviation | mm^2 | August 2011 |
|
Adverse events were monitored for the entire period of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GA Group | Patients with dry age related macular degeneration and geographic atrophy. |
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No adverse event were found or reported for this study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carmelina Gordon, MD | TLC Eyecare and Laser Centers | (517) 7821213 | shellie.fuentes@tlcmi.com |
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| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D057092 | Geographic Atrophy |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| Jackson |
| Michigan |
| 49202 |
| United States |
| 16723483 | Background | Hwang JC, Chan JW, Chang S, Smith RT. Predictive value of fundus autofluorescence for development of geographic atrophy in age-related macular degeneration. Invest Ophthalmol Vis Sci. 2006 Jun;47(6):2655-61. doi: 10.1167/iovs.05-1027. |
| 19320296 | Background | Lujan BJ, Rosenfeld PJ, Gregori G, Wang F, Knighton RW, Feuer WJ, Puliafito CA. Spectral domain optical coherence tomographic imaging of geographic atrophy. Ophthalmic Surg Lasers Imaging. 2009 Mar-Apr;40(2):96-101. doi: 10.3928/15428877-20090301-16. |
| 17270676 | Background | Sunness JS, Margalit E, Srikumaran D, Applegate CA, Tian Y, Perry D, Hawkins BS, Bressler NM. The long-term natural history of geographic atrophy from age-related macular degeneration: enlargement of atrophy and implications for interventional clinical trials. Ophthalmology. 2007 Feb;114(2):271-7. doi: 10.1016/j.ophtha.2006.09.016. |
| 21035861 | Background | Yehoshua Z, Rosenfeld PJ, Gregori G, Feuer WJ, Falcao M, Lujan BJ, Puliafito C. Progression of geographic atrophy in age-related macular degeneration imaged with spectral domain optical coherence tomography. Ophthalmology. 2011 Apr;118(4):679-86. doi: 10.1016/j.ophtha.2010.08.018. Epub 2010 Oct 29. |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Inter-device variability in measuring the area of Geographic Atrophy. 3 acceptable scans from 3 Cirrus HD-OCT devices (total of 9) were taken by one operator in this phase. |
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| 52 |
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| 52 |
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results until the device is released on the market.