Age-Related Macular DegenerationNCT01174407
Implication of CD35, CD21 and CD55 in Exudative 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 a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration. The aim is to asses a difference in expression rates of these factors on AMD-patients and a healthy control group. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- cd 35, cd21, cd55
- How many people
- 120 participants
- Where
- 1 siteAustria
- Study dates
- Sep 2008to Aug 2010
- 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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with exudative age-related macular degeneration, over 55
Who may be able to join
- Man and women over 18 years old
- Filled out informed consent
- Diagnosis of non-exudative/ exudative age related macular degeneneration
Who cannot join
- Inherited retinal diseases
- Other acquired retinal/ macular
- Missing informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is CD35, CD21 and CD55 Associated With Exudative Age-related Macular Degeneration
The purpose of this study is to determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration. The aim is to asses a difference in expression rates of these factors on AMD-patients and a healthy control group.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- cd 35, cd21, cd55
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cd 35, cd21, cd55Other
Blood drawing/ 10ml/ once- duration of 1 day of full examination of the patient
| Study group | Role | What they receive |
|---|---|---|
| cd35 | Not described Receives: Other: cd 35, cd21, cd55 |
What is being measured
The primary outcome is the main question the study is designed to answer.
determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration
Measured: 1 day
Secondary outcomes (1)
expression rates of on AMD-patients and a healthy control group
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionDec 2009 (estimated)
- Study completionAug 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rudolf Foundation Clinic
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01174407
- Sponsor's protocol ID
- EK08010-VK
- Status last verified
- Aug 2010
- First submitted
- 19 Nov 2008
- Last updated
- 3 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Haas P, Aggermann T, Nagl M, Steindl-Kuscher K, Krugluger W, Binder S. Implication of CD21, CD35, and CD55 in the pathogenesis of age-related macular degeneration. Am J Ophthalmol. 2011 Sep;152(3):396-399.e1. doi: 10.1016/j.ajo.2011.02.017. Epub 2011 Jun 12.
PubMed 21669404
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is CD35, CD21 and CD55 Associated With Exudative Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT01174407
- Acronym / sponsor ID
- EK08010-VK
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Rudolf Foundation ClinicUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Aug 2010 (estimated)
- First posted
- 3 Aug 2010 (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 a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration. The aim is to asses a difference in expression rates of these factors on AMD-patients and a healthy control group.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cd35 | – | Other: cd 35, cd21, cd55 |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with exudative age-related macular degeneration, over 55
Key inclusion criteria (3 listed)
- Man and women over 18 years old
- Filled out informed consent
- Diagnosis of non-exudative/ exudative age related macular degeneneration
Key exclusion criteria (3 listed)
- Inherited retinal diseases
- Other acquired retinal/ macular
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cd 35, cd21, cd55Blood drawing/ 10ml/ once- duration of 1 day of full examination of the patient | Other | cd35 |
Primary outcome
determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration
Time frame: 1 day
1 secondary outcome
expression rates of on AMD-patients and a healthy control group
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2010.
- Derived from this study: PubMed 21669404Haas P, Aggermann T, Nagl M, Steindl-Kuscher K, Krugluger W, Binder S. Implication of CD21, CD35, and CD55 in the pathogenesis of age-related macular degeneration. Am J Ophthalmol. 2011 Sep;152(3):396-399.e1. doi: 10.1016/j.ajo.2011.02.017. Epub 2011 Jun 12.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 Aug 2010. 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?
determine a possible implication of CD21, CD35 and CD55 in the pathogenesis of age-related macular degeneration (time frame: 1 day). 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 NCT01174407, which also lists 1 linked publication.
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 Aug 2010.