Age-related Macular DegenerationNCT01777984
Impact of Visceral Fat on the Pathogenesis of Age-related Macular Degeneration
An observational study of Age-related Macular Degeneration, run by Rudolf Foundation Clinic at 1 site in Austria.
Trial summary
The purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-related Macular Degeneration
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- Dec 2009to Dec 2013
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with age-related macular degeneration, over 60
Who may be able to join
- man and women over 18 years old
- filled informed consent
- diagnosis of age-related macular degeneration
Who cannot join
- inherited retinal disease
- other acquired retinal macular disease
- missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus.
Read the detailed description
In this study the investigators want to examine the relationship among visceral fat, serum leptin levels, and high-sensitive CRP (hsCRP), Tnf-alpha, Amyloid alpha and Amyloid Beta serum levels in patients with age-related macular degeneration in comparison to patients with a normal fundus.
- Conditions
- Age-related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
visceral fat ratio
Measured: 1 day
Secondary outcomes (1)
Leptin, Amyloid, TNF alpha, CRP
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startDec 2009
- Primary completionMay 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related 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-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rudolf Foundation Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susanne Binder, Principal investigator, Rudolf Foundation Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01777984
- Sponsor's protocol ID
- EK-08-122-0708
- Status last verified
- Jan 2013
- First submitted
- 1 Dec 2011
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Visceral Fat on the Pathogenesis of Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01777984
- Acronym / sponsor ID
- EK-08-122-0708
- Conditions
- Age-related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rudolf Foundation ClinicUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- May 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 29 Jan 2013 (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 purpose of this study is to determine the relationship among the body fat distribution, especially the visceral fat, in patients with age-related macular degeneration in comparison to patients with a normal fundus.
Detailed description
In this study the investigators want to examine the relationship among visceral fat, serum leptin levels, and high-sensitive CRP (hsCRP), Tnf-alpha, Amyloid alpha and Amyloid Beta serum levels in patients with age-related macular degeneration in comparison to patients with a normal fundus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with age-related macular degeneration, over 60
Key inclusion criteria (3 listed)
- man and women over 18 years old
- filled informed consent
- diagnosis of age-related macular degeneration
Key exclusion criteria (3 listed)
- inherited retinal disease
- other acquired retinal macular disease
- missing informed consent
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
visceral fat ratio
Time frame: 1 day
1 secondary outcome
Leptin, Amyloid, TNF alpha, CRP
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
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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.
Susanne Binder principal investigator
Rudolf Foundation Clinic
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 Macular Degeneration, run by Rudolf Foundation Clinic at 1 site in Austria.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 29 Jan 2013. 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 Austria. 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?
Results are not available in the source record.
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?
visceral fat ratio (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2013.