Diabetic RetinopathyCORISMAPNCT02876744
Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes
An observational study of Diabetic Retinopathy, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Retinopathy
- What is being tested?
- ophthalmologic examination
- How many people
- 101 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2017to 15 Dec 2020
- 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: Patients with diabetes, requiring follow-up with fluorescein angiography.
Who may be able to join
- diabetes type I or type II
- follow-up with fluorescein angiography
Who cannot join
- known allergy to fluorescein
- contra-indication to fluorescein angiography
- pregnant or breast-feeding patient
- technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.
Trial locations and contacts
1 site in 1 country.
About this study
The contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus.
This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.
- Conditions
- Diabetic Retinopathy
- Being tested
- ophthalmologic examination
- Medical subject headings
- Diabetic Retinopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ophthalmologic examinationOther
ophthalmologic examination including optical coherent tomography with angiography module
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection and measure of ischemic territories in central and peripheral retina
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2016 (estimated)
- Study start4 Apr 2017
- Primary completion13 Apr 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic RetinopathyStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Martine MAUGET FAYSSE, MD, Principal investigator, Fondation ophtalmologique de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02876744
- Sponsor's protocol ID
- MMT_2016_21
- Acronym
- CORISMAP
- Status last verified
- Jan 2021
- First submitted
- 19 Aug 2016
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Macular Ischemia and Peripheral Ischemia in Patients With Diabetes
- ClinicalTrials.gov ID
- NCT02876744
- Acronym / sponsor ID
- CORISMAP / MMT_2016_21
- Conditions
- Diabetic Retinopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 4 Apr 2017 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 24 Aug 2016 (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 contribution of OCT- angiography (OCT-A) allows to consider, in a more or less long term, a drastic reduction in the use of fluorescein angiographies in diabetic retinopathy. The accuracy of the analysis of the vascularization of retinal layers of the posterior pole of the eye by the OCT-A , will detect, early and in a quantifiable manner, whether or not there are areas of macular ischemia in a patient. However, current technical limitations (small field analysis) of OCT-A imaging only allow a limited study of retina at the posterior pole of the fundus.
This study seeks to demonstrate whether there is a link between macular ischemia detected by the OCT-A and peripheral retinal ischemia detected by the fluorescein angiographies, in diabetic patients.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diabetes, requiring follow-up with fluorescein angiography.
Key inclusion criteria (2 listed)
- diabetes type I or type II
- follow-up with fluorescein angiography
Key exclusion criteria (4 listed)
- known allergy to fluorescein
- contra-indication to fluorescein angiography
- pregnant or breast-feeding patient
- technical impossibility to analyse retinal ischemic areas on fluorescein angiography or OCT-A.
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 |
|---|---|---|
| ophthalmologic examinationophthalmologic examination including optical coherent tomography with angiography module | Other | – |
Primary outcome
Detection and measure of ischemic territories in central and peripheral retina
Time frame: immediate
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 14 Jan 2021.
- Individual participant dataSharing planned: No
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Diabetic Retinopathy
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.
Martine MAUGET FAYSSE, MD principal investigator
Fondation ophtalmologique de Rothschild
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 Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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 2 inclusion and 4 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 14 Jan 2021. 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 France. 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?
Detection and measure of ischemic territories in central and peripheral retina (time frame: immediate). 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 14 Jan 2021.