NCT01272076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

January 5, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2011

Completed
25 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 14, 2013

Completed
Last Updated

January 20, 2014

Status Verified

December 1, 2013

Enrollment Period

1 month

First QC Date

January 5, 2011

Results QC Date

June 24, 2013

Last Update Submit

December 17, 2013

Conditions

Age Related Macular DegenerationGeographic Atrophy

Keywords

Age Related Macular DegenerationGeographic AtrophyImagingOCT

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Dry AMD and geographic atrophy

Patients diagnosed with dry AMD and geographic atrophy

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary Care Clinic

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

East Bay Retina Consultants, Inc.

Oakland, California, 94609, United States

Location

TLC Eyecare and Laser Centers

Jackson, Michigan, 49202, United States

Location

Related Publications (6)

  • 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.

    PMID: 19171212BACKGROUND

  • 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.

    PMID: 17239336BACKGROUND

  • 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.

    PMID: 16723483BACKGROUND

  • 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.

    PMID: 19320296BACKGROUND

  • 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.

    PMID: 17270676BACKGROUND

  • 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.

    PMID: 21035861BACKGROUND

MeSH Terms

Conditions

Macular DegenerationGeographic Atrophy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Limitations and Caveats

No adverse event were found or reported for this study.

Results Point of Contact

Title
Carmelina Gordon, MD
Organization
TLC Eyecare and Laser Centers
shellie.fuentes@tlcmi.com
(517) 7821213

Study Officials

  • Carmelina M Gordon, MD

    TLC Eye Care and Laser Center

    PRINCIPAL INVESTIGATOR

  • Eugene S Lit, M.D.

    East Bay Retina Consultants

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2011

First Posted

January 7, 2011

Study Start

January 1, 2011

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

January 20, 2014

Results First Posted

November 14, 2013

Record last verified: 2013-12

Locations

US(2)