Age Related MaculopathyNCT00494325
The Role of Macular Pigment in Patients With Age-related Macular Degeneration
An observational study of Age Related Maculopathy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age Related Maculopathy
- How many people
- 480 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2005to 30 Apr 2018
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with early ARM
Who may be able to join
- age related maculopathy
Who cannot join
- other macular diseases
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Klinik und Poliklinik für Augenheilkunde, University Bern
Bern
About this study
In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. It has been demonstrated that the MP density can be increased by dietary supplementation. First results of MP density measurements with a modified confocal laser scanning ophthalmoscope show that this method allows to quantify the MP in a clinical setting. The aim of this study is to assess the peak MP density as well as the MP distribution in relation to the risk for ARMD. We will establish reference values for MP density distribution in a normal population and compare these to values obtained from patients with age related maculopathy in a cross-sectional study. For all MP density measurements we will use a modified scanning laser ophthalmoscope and dietary intake of macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and autofluorescence imaging. The results of our study will help assess the relationship of macular pigment density and distribution with ARMD. Additionally, we will be able to identify patients with low MP density, and probably improve the early diagnosis of patients at high risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or zeaxanthin in patients with high risk for ARMD due to low macular pigment values.
- Conditions
- Age Related Maculopathy
- Keywords
- age related maculopathy, macular pigment
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of development of late AMD
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2007 (estimated)
- Study startOct 2005
- Primary completionDec 2010
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Age Related MaculopathyStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastian Wolf, Insel Gruppe AG, University Hospital Bern
- Investigators
- Sebastian Wolf, MD, Principal investigator, University of BernSebastian Wolf, MD PhD, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494325
- Sponsor's protocol ID
- KEK 73/05
- Other IDs
- SNF 3200 Bo-109962/1
- Status last verified
- May 2018
- First submitted
- 27 Jun 2007
- Last updated
- 3 May 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolf-Schnurrbusch UE, Wittwer VV, Ghanem R, Niederhaeuser M, Enzmann V, Framme C, Wolf S. Blue-light versus green-light autofluorescence: lesion size of areas of geographic atrophy. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9497-502. doi: 10.1167/iovs.11-8346.
PubMed 22110076Rothenbuehler SP, Wolf-Schnurrbusch UE, Wolf S. Macular pigment density at the site of altered fundus autofluorescence. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):499-504. doi: 10.1007/s00417-010-1528-1. Epub 2010 Sep 28.
PubMed 20878175
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Macular Pigment in Patients With Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT00494325
- Acronym / sponsor ID
- KEK 73/05
- Conditions
- Age Related Maculopathy
- Keywords
- age related maculopathy, macular pigment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 29 Jun 2007 (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.
In the industrialised world age-related macular degeneration (ARMD) is the leading cause for legal blindness beyond the age of 50 years. Recent studies indicate that the amount and status of the macular pigment (MP) may play a central role in the development and progression of the disease. It has been demonstrated that the MP density can be increased by dietary supplementation. First results of MP density measurements with a modified confocal laser scanning ophthalmoscope show that this method allows to quantify the MP in a clinical setting. The aim of this study is to assess the peak MP density as well as the MP distribution in relation to the risk for ARMD. We will establish reference values for MP density distribution in a normal population and compare these to values obtained from patients with age related maculopathy in a cross-sectional study. For all MP density measurements we will use a modified scanning laser ophthalmoscope and dietary intake of macular pigment will be assessed using a Food Frequency Questionnaire. Clinical examinations will include ETDRS visual acuity, binocular ophthalmoscopy, colour fundus photography and autofluorescence imaging. The results of our study will help assess the relationship of macular pigment density and distribution with ARMD. Additionally, we will be able to identify patients with low MP density, and probably improve the early diagnosis of patients at high risk for developing ARMD. This will be the basis for dietary supplementation of lutein and/or zeaxanthin in patients with high risk for ARMD due to low macular pigment values.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with early ARM
Key inclusion criteria (1 listed)
- age related maculopathy
Key exclusion criteria (1 listed)
- other macular diseases
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
Incidence of development of late AMD
Time frame: End of study
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 3 May 2018.
- Derived from this study: PubMed 22110076Wolf-Schnurrbusch UE, Wittwer VV, Ghanem R, Niederhaeuser M, Enzmann V, Framme C, Wolf S. Blue-light versus green-light autofluorescence: lesion size of areas of geographic atrophy. Invest Ophthalmol Vis Sci. 2011 Dec 16;52(13):9497-502. doi: 10.1167/iovs.11-8346.
- Derived from this study: PubMed 20878175Rothenbuehler SP, Wolf-Schnurrbusch UE, Wolf S. Macular pigment density at the site of altered fundus autofluorescence. Graefes Arch Clin Exp Ophthalmol. 2011 Apr;249(4):499-504. doi: 10.1007/s00417-010-1528-1. Epub 2010 Sep 28.
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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.
Sebastian Wolf, MD principal investigator
University of Bern
Sebastian Wolf, MD PhD study director
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age Related Maculopathy, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 inclusion and 1 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 3 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
Incidence of development of late AMD (time frame: End of study). 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 NCT00494325, which also lists 2 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 3 May 2018.