Diabetic RetinopathyNCT00840541
Phenotyping Diabetic Retinopathy
An observational study of Diabetic Retinopathy, run by Association for Innovation and Biomedical Research on Light and Image at 1 site in Portugal.
Trial summary
The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- How many people
- 80 participants
- Where
- 1 sitePortugal
- Study dates
- Jan 2009to Jan 2012
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Type-2 diabetic subjects diagnosed with DR, followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center, with a previous follow-up in which systemic data and ophthalmological examinations were performed regularly.
Who may be able to join
- Diagnosis of DR.
- Females or Males;
- Age over 18 years;
- Signed Informed Consent;
- Previous follow-up with regular systemic and ophthalmic assessments.
Who cannot join
- Cataract or other eye disease that may interfere with fundus examinations;
- Vitreous syneresis or posterior vitreous detachment;
- 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
Official title: Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes
The purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).
Read the detailed description
This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.
Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.
- Conditions
- Diabetic Retinopathy
- Medical subject headings
- Diabetic Retinopathy
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 |
|---|---|---|
| DR | Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR). |
What is being measured
The primary outcome is the main question the study is designed to answer.
CSME
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 posted10 Feb 2009 (estimated)
- Study startJan 2009
- Primary completionJan 2010
- Study completionJan 2012
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 Diabetic RetinopathyStudies 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
- Retrospective
- Enrolment
- 80 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 Cunha-Vaz, MD PhD, Principal investigator, Association for Innovation and Biomedical Research on Light and Image
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00840541
- Sponsor's protocol ID
- CNTM018A
- Status last verified
- Apr 2014
- First submitted
- 9 Feb 2009
- Last updated
- 7 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Cunha-Vaz J. Characterization and relevance of different diabetic retinopathy phenotypes. Dev Ophthalmol. 2007;39:13-30. doi: 10.1159/000098497.
PubMed 17245076
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Type-2 Diabetic Subjects to Validate Diabetic Retinopathy Phenotypes
- ClinicalTrials.gov ID
- NCT00840541
- Acronym / sponsor ID
- CNTM018A
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Association for Innovation and Biomedical Research on Light and ImageUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 10 Feb 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 purpose of this study is to validate and characterize phenotypes of diabetic retinopathy (DR) progression based on available clinical data (demographic, systemic and ophthalmic data).
Detailed description
This study aims to validate and characterize phenotypes of diabetic retinopathy (DR) progression using ophthalmic and systemic data from type-2 diabetic subjects followed at the AIBILI Clinical Trial Center in the last 10 years.
Macular Edema (ME) development during the study period, mainly Clinically Significant ME (CSME) needing treatment, will be the primary indicator for DR progression. CSME will be considered as the primary end-point and will be used to identify phenotypes (and risk markers) of DR progression.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DR | – | –Type-2 diabetic subjects diagnosed with diabetic retinopathy (DR). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Type-2 diabetic subjects diagnosed with DR, followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center, with a previous follow-up in which systemic data and ophthalmological examinations were performed regularly.
Key inclusion criteria (5 listed)
- Diagnosis of DR.
- Females or Males;
- Age over 18 years;
- Signed Informed Consent;
- Previous follow-up with regular systemic and ophthalmic assessments.
Key exclusion criteria (3 listed)
- Cataract or other eye disease that may interfere with fundus examinations;
- Vitreous syneresis or posterior vitreous detachment;
- 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
CSME
Time frame: 1 year
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 7 Apr 2014.
- Background: PubMed 17245076Cunha-Vaz J. Characterization and relevance of different diabetic retinopathy phenotypes. Dev Ophthalmol. 2007;39:13-30. doi: 10.1159/000098497.
- Related InfoLink provided by the sponsor.
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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 Cunha-Vaz, MD PhD 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 Diabetic Retinopathy, 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 5 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 7 Apr 2014. 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?
CSME (time frame: 1 year). 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 NCT00840541, 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 7 Apr 2014.