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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
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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
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Estimation of visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) | Estimation of visual acuity after 96 weeks of treatment with Aflibercept | 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the central macular thickness | Describe the evolution of the Central macular thickness during treatment | 96 weeks |
| Quantification of number of Aflibercept injections received | 96 weeks |
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Inclusion Criteria:
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
Exclusion Criteria:
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Diabetic vitrectomised patients with macular edema, treated with Aflibercept in the past
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| Name | Affiliation | Role |
|---|---|---|
| Thi Ha Chau TRAN, PhD | Groupement des Hôpitaux de l'Institut Catholique de Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pr MILAZZO Solange | Amiens | Hauts-de-France | 80000 | France | ||
| Tran Thi Ha Chau |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34007150 | Derived | 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. |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| Lomme |
| Hauts-de-France |
| 59160 |
| France |
| Stéphanie BAILLIF | Nice | PACA | 06001 | France |
| Dr DOMINGUEZ | Bordeaux | 33000 | France |
| Pr KODJIKIAN | Lyon | 69004 | France |
| Dr Franck BECQUET | Nantes | 44300 | France |
| Dr UZZAN | Rouen | 76100 | France |
| Bénédicte DUPAS | Paris | Île-de-France Region | 75010 | France |
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |