Diabetic Macular EdemaDOCTANCT03783832
Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
An observational study of Diabetic Macular Edema, run by Aquitania Opthalmologica at 6 sites in France.
Trial summary
This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema
- What is being tested?
- OCT ANGIOGRAPHY DATA
- How many people
- 48 participants
- Where
- 6 sitesFrance
- Study dates
- 19 Jun 2018to 31 Dec 2019
- 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 Diabetic Macular Edema
Who may be able to join
- Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).
- Patients with type I or II diabetes (as defined by criteria of American diabetes association ADA or world health organization WHO) with an glycosylated hemoglobin rate (HbA1c) < 10.0%, at initial visit (First EYLEA® injection).
- Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).
- Patients showing a visual lost due to a diabetic macular edema (DME) in the central region and not for another reason, assessed by the investigateur. The visual acuity of the fellow eye is not an exclusion criteria.
- Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.
- Patients affiliated to social security system.
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- Patient who has been given appropriate information about the study objectives and instructions who has given his/her non-opposition prior to conduct any study-related procedures and examination.
- Non iclusion Criteria:
- Treatment with an anti VEGF (EYLEA®, LUCENTIS® or AVASTIN®) administrated by intravitreal injection within 3 months prior to initial visit in the study eye
- Treatment with Ozurdex® administrated by intravitreal injection within 6 months prior to initial visit (First EYLEA® injection) in the study eye
- History of or active ocular /intraocular inflammation (Uveitis) at initial visit (First EYLEA® injection), in either eye
- Intra-ocular pressure ≥ 25 mmHg
- Patient with neocascular glaucoma history
- Patient with foveolar exsudat that interfere with images analysis.
- History or current evidence of hypersentivity to mydriatic eye drops
- Vitreomacular traction in the study eye
- Panretinal coagulation within 3 months prior to initial visit (First EYLEA® injection), in the study eye.
- Cataract surgery in the study eye within the 6 months prior to initial visit (First EYLEA® injection)
- History of vitretectomy in the study eye
- Treatment with systemic anti VEGF medications for cancer
- History of cerebrovascular accident within 3 months prior to initial visit (First EYLEA® injection), renal failure, uncontrolled arterial hypertension (PAS>160 mm Hg and/ or PAD>100 mm Hg)
- Patient who does not meet the local indication criteria for Eylea® treatment. Contraindications listed in the SmPCs must be taken into account
- Participation in any investigational study with exclusion period in progress at the initial visit (First EYLEA® injection)
- Patients under guardianship
- Pregnant or breastfeeding woman.
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites, 6 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Jean-François KOROBELNIK
- Recruiting
CHU Dijon
Dijon
Catherine CREUZOT-GARCHER
- Recruiting
Hôpital de la Croix-Rousse
Lyon
Laurent KODJIKIAN
- Recruiting
CHU Nantes
Nantes
Michel WEBER
- Recruiting
CHU Nice
Nice
Stéphanie BAILLIF
- Recruiting
CHU Strasbourg
Strasbourg
David GAUCHER
About this study
This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.
- Conditions
- Diabetic Macular Edema
- Being tested
- OCT ANGIOGRAPHY DATA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT ANGIOGRAPHY DATAOther
Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative data from OCT angiography
The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography
Measured: 1 Year
Quantitative data from OCT angiography
The perfusion density assessment (%) measured by OCT angiography
Measured: 1 Year
Quantitative data from OCT angiography
The vascular density assessment (%) measured by OCT angiography
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 posted21 Dec 2018
- Study start19 Jun 2018
- Primary completion31 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular EdemaStudies 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
- Other
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aquitania Opthalmologica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783832
- Sponsor's protocol ID
- 2017-A03478-45
- Acronym
- DOCTA
- Status last verified
- Dec 2018
- First submitted
- 19 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Diabetic Macular Edema Treated by Aflibercept (Eylea®) With OCT-Angiography
- ClinicalTrials.gov ID
- NCT03783832
- Acronym / sponsor ID
- DOCTA / 2017-A03478-45
- Conditions
- Diabetic Macular Edema
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Aquitania OpthalmologicaUniversity, hospital or other
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 21 Dec 2018 (actual)
- 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.
This is a non-interventional, longitudinal, retrospective and prospective, non-controlled, single arm study in naive or non-naive patients with diabetic macular edema for which aflibercept (EYLEA®) therapy is indicated.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Diabetic Macular Edema
Key inclusion criteria (25 listed)
- Man or woman aged 18 years and more under reliable method of contraception for woman with childbearing potential (hormonal or any intrauterine devices).
- Patients with type I or II diabetes (as defined by criteria of American diabetes association ADA or world health organization WHO) with an glycosylated hemoglobin rate (HbA1c) < 10.0%, at initial visit (First EYLEA® injection).
- Patients with diabetes treatment unchanged within the last 3 months prior to initial visit (First EYLEA® injection).
- Patients showing a visual lost due to a diabetic macular edema (DME) in the central region and not for another reason, assessed by the investigateur. The visual acuity of the fellow eye is not an exclusion criteria.
- Patient to whom a treatment by aflibercept is indicated and OCT-angiography is performed at each injection visit.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| OCT ANGIOGRAPHY DATAFollow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography | Other | – |
Primary outcome
Quantitative data from OCT angiography
Time frame: 1 Year
The macular perfusion measurement with Foveal Avascular Zone assessment (area in mm2, boundary in mm, circularity in %) measured by OCT angiography
Quantitative data from OCT angiography
Time frame: 1 Year
The perfusion density assessment (%) measured by OCT angiography
Quantitative data from OCT angiography
Time frame: 1 Year
The vascular density assessment (%) measured by OCT angiography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2018.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Macular Edema, run by Aquitania Opthalmologica at 6 sites 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 25 inclusion and 0 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 21 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact KOROBELNIK (33 5 57 82 12 16, jean-francois.korobelnik@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative data from OCT angiography (time frame: 1 Year). The study lists 3 primary outcomes in all. 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 21 Dec 2018.