Drusen Stage Macular DegenerationNCT01272063

Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography

An observational study of Drusen Stage Macular Degeneration, run by Carl Zeiss Meditec, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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). Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Drusen Stage Macular Degeneration
How many people: 91 participants
Where: 4 sitesUnited States
Study dates: Nov 2010to Feb 2011
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: Primary Care Clinic

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

TLC Eyecare and Laser Centers
Lansing, Michigan, 48912
Bascom Palmer Eye Institute
Miami, Florida, 33136
East Bay Retina
Oakland, California, 94609
West Coast Retina
San Francisco, California, 94107-1756

Other trials in United States

About this study

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).

Read the detailed description

This is a prospective, multiple site study. Ocular history and examination will be conducted on consented subjects to determine further participation in the study. Subjects qualified to continue will undergo color fundus photography and imaging of their study eye using the Cirrus HD-OCT.

Conditions: Drusen Stage Macular Degeneration
Keywords: Drusen, Dry AMD, OCT, Imaging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01272063
Study group	Role	What they receive
Dry AMD with macular drusen		Patients diagnosed with dry AMD with macular drusen

What is being measured

The primary outcome is the main question the study is designed to answer.

To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
Measured: 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.
Measured: Study was released before December 1, 2012

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010Feb 2011

First posted7 Jan 2011 (estimated)
Study startNov 2010
Primary completionFeb 2011
Study completionFeb 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for Drusen Stage Macular DegenerationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 91 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01272063
Sponsor's protocol ID: HD-OCT-DR-2010-1
Status last verified: Jun 2013
First submitted: 5 Jan 2011
Last updated: 25 Jun 2013
Results posted: No
Data monitoring committee: Yes

Publications

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.
PubMed 20547953
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.
PubMed 20399926
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.
PubMed 18697811
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.
PubMed 20393117
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.
PubMed 18301035
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.
PubMed 19797228
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.
PubMed 17396693
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.
PubMed 20007824
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.
PubMed 19259255

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Measurement and Analysis of Macular Retinal Pigment Epithelium (RPE) Elevations With Cirrus HD-OCT vs. Color Fundus Photography
ClinicalTrials.gov ID: NCT01272063
Acronym / sponsor ID: HD-OCT-DR-2010-1
Conditions: Drusen Stage Macular Degeneration
Keywords: Drusen, Dry AMD, OCT, Imaging
Study type: Observational
Recruitment status: Completed
Enrolment: 91 participants (actual)
Lead sponsor: Carl Zeiss Meditec, Inc.Industry (pharma, biotech, devices)
Collaborators: DataMed Devices Inc.
Study start: Nov 2010
Primary completion: Feb 2011 (actual)
Study completion: Feb 2011 (actual)
First posted: 7 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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).

Detailed description

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Dry AMD with macular drusen	–	–Patients diagnosed with dry AMD with macular drusen

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Primary Care Clinic

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs.
Time frame: Study was released before December 1, 2012

1 secondary outcome

To describe the clinical factors that affected the automated segmentation of elevated RPE by the Cirrus HD-OCT.
Time frame: Study was released before December 1, 2012

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2013.
Background: PubMed 20547953Klein 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.
Background: PubMed 20399926Varma 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.
Background: PubMed 18697811Yi 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.
Background: PubMed 20393117Jain 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.
Background: PubMed 18301035Stopa 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.
Background: PubMed 19797228Ahlers 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.
Background: PubMed 17396693Friberg 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.
Background: PubMed 20007824Munch 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.
Background: PubMed 19259255Wojtkowski 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Philip Rosenfeld, MD principal investigator

Bascom Palmer Eye Institute

Carmelina Gordon, MD principal investigator

TLC Eyecare and Laser Center

Eugene Lit, MD principal investigator

East Bay Retina Consultants

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Drusen Stage Macular Degeneration, run by Carl Zeiss Meditec, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To compare area measurements of elevated RPE as observed in the Cirrus HD-OCT versus those designated as drusen on color fundus photographs. (time frame: Study was released before December 1, 2012). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01272063, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2013.