The Most Effective Treatment Strategy for Diabetic Macular Edema. - METS for DME

The Rotterdam Eye Hospital0 个研究点开始时间: 2012年9月6日最近更新: 2012年12月10日

适应症

试验速览

暂无简介。

•1.Age = 18 years.
•2.Able to read and sign the written informed consent.
•3.Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT = 340 micron (see Section 7.1 for argumentation for chosen cut-off value).
•4.VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart (Snellen decimal equivalent: 0.08 – 0.63).
•5.If both eyes are eligible, the eye with the highest CFT will be selected as the study eye. If both eyes have equal CFT, the eye with the most recent record of presence of DME will be selected as the study eye. The fellow eye will receive treatment according to the current standard of care at the investigator’s discretion.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 120
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 336

•1.Previous laser photocoagulation therapy within the last 6 months.
•2.Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months.
•3.Previous subtenon’s or intravitreal triamcinolone injection within the last 6 months.
•4.Steroid implants of any kind within the last 3 years.
•5.Macular ischemia confirmed by fluorescein angiography (FA).
•6.Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT.
•7.Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia.
•8.Any ocular surgery/intervention within last three months before enrollment.
•9.Any ocular surgery/intervention anticipated during the course of the study.
•10.Ocular opacities hampering adequate imaging of the posterior pole.
•11.Poor control of DM with glycated hemoglobin (HbA1c) of = 86% in last 6 months.
•12.Allergy to fluorescein or anti-VEGF, or any of its preservatives.
•13.Pregnancy.
•14.Non-Caucasian or Asian descent.

发起方

The Rotterdam Eye Hospital