Age-Related MaculopathyNCT00759044
Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function
An observational study of Age-Related Maculopathy and Diabetic Macular Edema, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Age-Related Maculopathy, Diabetic Macular Edema
- How many people
- 90 participants
- Where
- 1 sitePortugal
- Study dates
- Mar 2008to Oct 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with AMD or DME followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center will be asked to perform additional optical examinations as a continuation of the routine fluorescein angiographies (FA).
Who may be able to join
- Patients diagnosed with AMD, or
- Patients diagnosed with DME
- Age over 18 years
- Inform consent
Who cannot join
- Cataract or other eye disease that may interfere with fundus examinations
- Glaucoma
- Dilatation of the pupil < 5 mm
Trial locations and contacts
1 site in 1 country.
Portugal1 site
AIBILI Clinical Trial Center
Coimbra, Coimbra District, 3000-548
About this study
To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.
- Conditions
- Age-Related Maculopathy, Diabetic Macular Edema
- Medical subject headings
- Macular Degeneration
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 |
|---|---|---|
| AMD | Patients diagnosed with AMD | |
| DME | Patients diagnosed with DME |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2010
- Study completionOct 2010
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 MaculopathyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and Image
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- José G Cunha-Vaz, Prof., Principal investigator, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00759044
- Sponsor's protocol ID
- CNTM023A
- Status last verified
- Oct 2015
- First submitted
- 24 Sep 2008
- Last updated
- 15 Oct 2015
- Results posted
- No
Publications
Bernardes R, Dias J, Cunha-Vaz J. Mapping the human blood-retinal barrier function. IEEE Trans Biomed Eng. 2005 Jan;52(1):106-16. doi: 10.1109/TBME.2004.839801.
PubMed 15651569
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function
- ClinicalTrials.gov ID
- NCT00759044
- Acronym / sponsor ID
- CNTM023A
- Conditions
- Age-Related Maculopathy, Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 25 Sep 2008 (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.
To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AMD | – | –Patients diagnosed with AMD |
| DME | – | –Patients diagnosed with DME |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with AMD or DME followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center will be asked to perform additional optical examinations as a continuation of the routine fluorescein angiographies (FA).
Key inclusion criteria (4 listed)
- Patients diagnosed with AMD, or
- Patients diagnosed with DME
- Age over 18 years
- Inform consent
Key exclusion criteria (3 listed)
- Cataract or other eye disease that may interfere with fundus examinations
- Glaucoma
- Dilatation of the pupil < 5 mm
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
Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).
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 15 Oct 2015.
- Background: PubMed 15651569Bernardes R, Dias J, Cunha-Vaz J. Mapping the human blood-retinal barrier function. IEEE Trans Biomed Eng. 2005 Jan;52(1):106-16. doi: 10.1109/TBME.2004.839801.
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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.
José G Cunha-Vaz, Prof. principal investigator
Association for Innovation and Biomedical Research on Light and Image
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 and Diabetic Macular Edema, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
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 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: finished, as of the sponsor's last update on 15 Oct 2015. 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 Portugal. 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?
Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).. 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 NCT00759044, 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 15 Oct 2015.