NCT01272063

Brief Summary

The objective of this study is to compare the areas designated as elevated retinal pigment epithelium (RPE) by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs (CFPs).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
91

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2010

Shorter than P25 for all trials

Geographic Reach
1 country

4 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

November 1, 2010

Completed
2 months 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
Last Updated

June 25, 2013

Status Verified

June 1, 2013

Enrollment Period

3 months

First QC Date

January 5, 2011

Last Update Submit

June 24, 2013

Conditions

Drusen Stage Macular Degeneration

Keywords

DrusenDry AMDOCTImaging

Outcome Measures

Primary Outcomes (1)

  • To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.

    Study was released before December 1, 2012

Secondary Outcomes (1)

  • To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.

    Study was released before December 1, 2012

Other Outcomes (1)

  • To describe the qualitative similarities and differences between the areas designated as elevated RPE by the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.

    Study was released before December 1, 2012

Study Arms (1)

Dry AMD with macular drusen

Patients diagnosed with dry AMD with macular drusen

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 or older diagnosed to have dry AMD with macular drusen.
  • Drusen should not be combined with other lesions such as geographic atrophy (GA) or choroidal neovascularization.
  • Able and willing to make the required study visits.
  • 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 visits.
  • Unable to give consent or follow study instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

East Bay Retina

Oakland, California, 94609, United States

Location

West Coast Retina

San Francisco, California, 94107-1756, United States

Location

Bascom Palmer Eye Institute

Miami, Florida, 33136, United States

Location

TLC Eyecare and Laser Centers

Lansing, Michigan, 48912, United States

Location

Related Publications (9)

  • Klein R, Cruickshanks KJ, Nash SD, Krantz EM, Nieto FJ, Huang GH, Pankow JS, Klein BE. The prevalence of age-related macular degeneration and associated risk factors. Arch Ophthalmol. 2010 Jun;128(6):750-8. doi: 10.1001/archophthalmol.2010.92.

    PMID: 20547953BACKGROUND

  • Varma R, Foong AW, Lai MY, Choudhury F, Klein R, Azen SP; Los Angeles Latino Eye Study Group. Four-year incidence and progression of age-related macular degeneration: the Los Angeles Latino Eye Study. Am J Ophthalmol. 2010 May;149(5):741-51. doi: 10.1016/j.ajo.2010.01.009.

    PMID: 20399926BACKGROUND

  • Yi K, Mujat M, Park BH, Sun W, Miller JW, Seddon JM, Young LH, de Boer JF, Chen TC. Spectral domain optical coherence tomography for quantitative evaluation of drusen and associated structural changes in non-neovascular age-related macular degeneration. Br J Ophthalmol. 2009 Feb;93(2):176-81. doi: 10.1136/bjo.2008.137356. Epub 2008 Aug 12.

    PMID: 18697811BACKGROUND

  • Jain N, Farsiu S, Khanifar AA, Bearelly S, Smith RT, Izatt JA, Toth CA. Quantitative comparison of drusen segmented on SD-OCT versus drusen delineated on color fundus photographs. Invest Ophthalmol Vis Sci. 2010 Oct;51(10):4875-83. doi: 10.1167/iovs.09-4962. Epub 2010 Apr 14.

    PMID: 20393117BACKGROUND

  • Stopa M, Bower BA, Davies E, Izatt JA, Toth CA. Correlation of pathologic features in spectral domain optical coherence tomography with conventional retinal studies. Retina. 2008 Feb;28(2):298-308. doi: 10.1097/IAE.0b013e3181567798.

    PMID: 18301035BACKGROUND

  • Ahlers C, Gotzinger E, Pircher M, Golbaz I, Prager F, Schutze C, Baumann B, Hitzenberger CK, Schmidt-Erfurth U. Imaging of the retinal pigment epithelium in age-related macular degeneration using polarization-sensitive optical coherence tomography. Invest Ophthalmol Vis Sci. 2010 Apr;51(4):2149-57. doi: 10.1167/iovs.09-3817. Epub 2009 Sep 24.

    PMID: 19797228BACKGROUND

  • Friberg TR, Huang L, Palaiou M, Bremer R. Computerized detection and measurement of drusen in age-related macular degeneration. Ophthalmic Surg Lasers Imaging. 2007 Mar-Apr;38(2):126-34. doi: 10.3928/15428877-20070301-07.

    PMID: 17396693BACKGROUND

  • Munch IC, Ek J, Kessel L, Sander B, Almind GJ, Brondum-Nielsen K, Linneberg A, Larsen M. Small, hard macular drusen and peripheral drusen: associations with AMD genotypes in the Inter99 Eye Study. Invest Ophthalmol Vis Sci. 2010 May;51(5):2317-21. doi: 10.1167/iovs.09-4482. Epub 2009 Dec 10.

    PMID: 20007824BACKGROUND

  • Wojtkowski M, Sikorski BL, Gorczynska I, Gora M, Szkulmowski M, Bukowska D, Kaluzny J, Fujimoto JG, Kowalczyk A. Comparison of reflectivity maps and outer retinal topography in retinal disease by 3-D Fourier domain optical coherence tomography. Opt Express. 2009 Mar 2;17(5):4189-207. doi: 10.1364/oe.17.004189.

    PMID: 19259255BACKGROUND

Study Officials

  • Philip Rosenfeld, MD

    Bascom Palmer Eye Institute

    PRINCIPAL INVESTIGATOR

  • Carmelina Gordon, MD

    TLC Eyecare and Laser Center

    PRINCIPAL INVESTIGATOR

  • Eugene Lit, MD

    East Bay Retina Consultants

    PRINCIPAL INVESTIGATOR

  • Brandon Lujan, MD

    West Coast Retina

    PRINCIPAL INVESTIGATOR

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

November 1, 2010

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

June 25, 2013

Record last verified: 2013-06

Locations

US(4)