Diabetic Macular EdemaMODEVANCT02874859
Intravitreal Aflibercept InjectiOn in Vitrectomized Eyes for Treatment of Diabetic Macular Edema
An observational study of Diabetic Macular Edema, run by Lille Catholic University at 8 sites in France.
Trial summary
This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Macular Edema
- How many people
- 49 participants
- Where
- 8 sitesFrance
- Study dates
- 9 Nov 2016to 19 Aug 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past
Who may be able to join
- Diabetic patients aged between 19 and 90 years old
- Patients with the following characteristics at the beginning of the Aflibercept therapy :
- HbA1c < 9% Diabetic macular oedema with the central affected Visual acuity between 1/20 and 5/40 (between 20 and 70 letters ETRS) Patients who had a vitrectomy over 3 months ago
- Patients who did not received an anti-VEGF treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections
Who cannot join
- Patients who refused the collection of their data in medical records
- Patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion
- Patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion)
- Pregnancy at the moment of inclusion
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Pr MILAZZO Solange
Amiens, Hauts-de-France, 80000
Dr DOMINGUEZ
Bordeaux, 33000
Tran Thi Ha Chau
Lomme, Hauts-de-France, 59160
Pr KODJIKIAN
Lyon, 69004
Dr Franck BECQUET
Nantes, 44300
Stéphanie BAILLIF
Nice, PACA, 06001
Bénédicte DUPAS
Paris, Île-de-France Region, 75010
Dr UZZAN
Rouen, 76100
About this study
Official title: Aflibercept Injection for Treatment of Diabetic Macular Edema
This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema
Read the detailed description
Diabetic macular edema (DME) is the leading cause of blindness among people of working age. Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab, Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of DME. Aflibercept, one of the drugs in this group has recently been approved in France. However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and tolerance of Aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by Aflibercept in the past.
- Conditions
- Diabetic Macular Edema
- Keywords
- DIABETIC RETINOPATHY, Intravitreal aflibercept
- Medical subject headings
- Diabetic Retinopathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
Estimation of visual acuity after 96 weeks of treatment with Aflibercept
Measured: 96 weeks
Secondary outcomes (2)
Measure of the central macular thickness
Describe the evolution of the Central macular thickness during treatment
Measured: 96 weeks
Quantification of number of Aflibercept injections received
Measured: 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2016 (estimated)
- Study start9 Nov 2016
- Primary completion19 Aug 2020
- Study completion19 Aug 2020
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 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lille Catholic University
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer
- Responsible party
- Sponsor
- Investigators
- Thi Ha Chau TRAN, PhD, Principal investigator, Groupement des Hôpitaux de l'Institut Catholique de Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02874859
- Sponsor's protocol ID
- RC-P0051
- Acronym
- MODEVA
- Status last verified
- Feb 2021
- First submitted
- 17 Aug 2016
- Last updated
- 5 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Tran THC, Erginay A, Verdun S, Fourmaux E, Le Rouic JF, Uzzan J, Milazzo S, Baillif S, Kodjikian L. One-Year Outcome of Aflibercept Intravitreal Injection in Vitrectomized Eyes with Diabetic Macular Edema. Clin Ophthalmol. 2021 May 11;15:1971-1978. doi: 10.2147/OPTH.S304030. eCollection 2021.
PubMed 34007150
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aflibercept Injection for Treatment of Diabetic Macular Edema
- ClinicalTrials.gov ID
- NCT02874859
- Acronym / sponsor ID
- MODEVA / RC-P0051
- Conditions
- Diabetic Macular Edema
- Keywords
- DIABETIC RETINOPATHY, Intravitreal aflibercept
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Lille Catholic UniversityUniversity, hospital or other
- Collaborators
- Bayer
- Study start
- 9 Nov 2016 (actual)
- Primary completion
- 19 Aug 2020 (actual)
- Study completion
- 19 Aug 2020 (actual)
- First posted
- 22 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.
This a non-interventional retrospective study on the efficiency and the tolerance of intravitreal injections of Aflibercept on vitrectomized eyes in the diabetic macular oedema
Detailed description
Diabetic macular edema (DME) is the leading cause of blindness among people of working age. Treatment of DME included blood pressure and glycemic control, grid laser, intravitreal injection of steroids (acetonide of triamcinolone, dexamethasone implant, fluocinolone implant) or anti-Vascular endothelial growth factor (VEGF) therapy (Bevacizumab, Ranibizumab, Aflibercept) (2015). The advent of anti-VEGF therapy has revolutionized the management of DME. Aflibercept, one of the drugs in this group has recently been approved in France. However, there is no report in the efficacy and tolerance of Aflibercept in vitrectomized eyes in the diabetic macular oedema . In this study, in order to prove the efficiency and tolerance of Aflibercept, data will be collected in a anonymous way in medical records of patients having received a treatment by Aflibercept in the past.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past
Key inclusion criteria (4 listed)
- Diabetic patients aged between 19 and 90 years old
- Patients with the following characteristics at the beginning of the Aflibercept therapy :
- HbA1c < 9% Diabetic macular oedema with the central affected Visual acuity between 1/20 and 5/40 (between 20 and 70 letters ETRS) Patients who had a vitrectomy over 3 months ago
- Patients who did not received an anti-VEGF treatment or any other treatment for their diabetic macular edema 3 months before the beginning of the injections
Key exclusion criteria (4 listed)
- Patients who refused the collection of their data in medical records
- Patients with a macular ischemia of more than 1500µm diagnosed via an avascular central fluorescein angiography before the inclusion
- Patients with a recent cardiovascular incident (heart attack, stroke dating for less than 3 months before the inclusion)
- Pregnancy at the moment of inclusion
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
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS)
Time frame: 96 weeks
Estimation of visual acuity after 96 weeks of treatment with Aflibercept
2 secondary outcomes
Measure of the central macular thickness
Time frame: 96 weeks
Quantification of number of Aflibercept injections received
Time frame: 96 weeks
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 5 Feb 2021.
- Derived from this study: PubMed 34007150Tran THC, Erginay A, Verdun S, Fourmaux E, Le Rouic JF, Uzzan J, Milazzo S, Baillif S, Kodjikian L. One-Year Outcome of Aflibercept Intravitreal Injection in Vitrectomized Eyes with Diabetic Macular Edema. Clin Ophthalmol. 2021 May 11;15:1971-1978. doi: 10.2147/OPTH.S304030. eCollection 2021.
- Individual participant dataSharing planned: No
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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.
Thi Ha Chau TRAN, PhD principal investigator
Groupement des Hôpitaux de l'Institut Catholique de Lille
8 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 Lille Catholic University at 8 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 4 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 5 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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?
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?
Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) (time frame: 96 weeks). 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 NCT02874859, 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 5 Feb 2021.