Study of the Safety and Efficacy of APX3330 in Diabetic Retinopathy
NCT04692688
Cardiovascular Diseases, Diabetes Complications
Phoenix, Arizona, United States
View Trial DetailsNCT Number: NCT02874859
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
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Notify Me18 year–90 year
All sexes
Observational
Pr MILAZZO Solange, Amiens, Hauts-de-France, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Time frame: 96 weeks
Estimation of visual acuity after 96 weeks of treatment with Aflibercept
Time frame: 96 weeks
Describe the evolution of the Central macular thickness during treatment
Time frame: 96 weeks
Lille Catholic University
Other
Aflibercept Injection for Treatment of Diabetic Macular Edema
Acronym: MODEVA
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