Clinical trial NCT01272076: Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Official title: Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Geographic Atrophy
Keywords: Age Related Macular Degeneration
Geographic Atrophy
Imaging
OCT
Lead sponsor: Carl Zeiss Meditec, Inc.
Sponsor class: INDUSTRY
First posted: 2011-01-07
Enrollment: 85
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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).
timeFrame: August 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Oakland
country: United States
facility: East Bay Retina Consultants, Inc.
state: California
city: Jackson
country: United States
facility: TLC Eyecare and Laser Centers
state: Michigan
Study officials:
affiliation: TLC Eye Care and Laser Center
name: Carmelina M Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: East Bay Retina Consultants
name: Eugene S Lit, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.