Diabetic Macular Edema
Conditions
Keywords
DIABETIC RETINOPATHY, Intravitreal aflibercept
Brief 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
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.
Interventions
None listed
Sponsors
Bayer
Lille Catholic University
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) | 96 weeks | Estimation of visual acuity after 96 weeks of treatment with Aflibercept |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure of the central macular thickness | 96 weeks | Describe the evolution of the Central macular thickness during treatment |
| Quantification of number of Aflibercept injections received | 96 weeks | — |
Countries
France
Outcome results
None listed