UveitisNCT00956124
Autofluorescence in Uveitic and Diabetic Macular Edema
An observational study of Uveitis and Macular Edema, run by St. Franziskus Hospital at 1 site in Germany.
Trial summary
The aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Uveitis, Macular Edema
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2010to 1 Jun 2016
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with uveitis or diabetes
Who may be able to join
- patients with diabetic or uveitis macular edema
Who cannot join
- children patients with known allergy to fluorescein
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Ophthalmology at St Franziskus Hospital
Münster, North-Rhine-Westfalia, 48145
About this study
The aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered.
Read the detailed description
After macular pigment measuring we will perform fundus autofluorescence, fluorescein angiography and optical coherence tomography. any associations of macular pigment distribution and fundus autofluorescence with macular anatomic features are analyzed. primary outcome measure is the macular pigment distribution in patients with altered fundus autofluorescence. Furthermore we will compare the findings between diabetic and inflammatory edema.
- Conditions
- Uveitis, Macular Edema
- Medical subject headings
- Uveitis, Macular Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| uveitic patients | Not described | |
| patients with diabetes | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2009 (estimated)
- Study startOct 2010
- Primary completionOct 2011
- Study completion1 Jun 2016
Why it stopped: Technical issue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UveitisStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Franziskus Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carsten Heinz, St. Franziskus Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00956124
- Sponsor's protocol ID
- 2009-017-f-S
- Status last verified
- Apr 2017
- First submitted
- 10 Aug 2009
- Last updated
- 25 Apr 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autofluorescence in Uveitic and Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT00956124
- Acronym / sponsor ID
- 2009-017-f-S
- Conditions
- Uveitis, Macular Edema
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Technical issue
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Franziskus HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 11 Aug 2009 (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 aim of this study is to determine whether fundus autofluorescence and macular pigment distribution in inflammatory and diabetic macular edema are altered.
Detailed description
After macular pigment measuring we will perform fundus autofluorescence, fluorescein angiography and optical coherence tomography. any associations of macular pigment distribution and fundus autofluorescence with macular anatomic features are analyzed. primary outcome measure is the macular pigment distribution in patients with altered fundus autofluorescence. Furthermore we will compare the findings between diabetic and inflammatory edema.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| uveitic patients | – | – |
| patients with diabetes | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with uveitis or diabetes
Key inclusion criteria (1 listed)
- patients with diabetic or uveitis macular edema
Key exclusion criteria (1 listed)
- children patients with known allergy to fluorescein
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
Not reported in the source record.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
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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 Uveitis and Macular Edema, run by St. Franziskus Hospital at 1 site in Germany.
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: withdrawn, as of the sponsor's last update on 25 Apr 2017. 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 Germany. 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 was withdrawn before enrolling participants, so there are no results.
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.
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 25 Apr 2017.