The Most Effective Treatment Strategy for Diabetic Macular Edema.
- Conditions
- diabetic macular edema1001265310015917
- Registration Number
- NL-OMON39983
- Lead Sponsor
- Oogziekenhuis Rotterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 456
Age * 18 years.
Able to read and sign the written informed consent.
Diagnosis of DME, based on ETDRS criteria and confirmed by macular edema on optical coherence tomography (OCT, Heidelberg Spectralis), defined as CFT * 340 micron.
VA loss due to DME, with VA being between 45 and 85 letters as measured on ETDRS chart.
If both eyes are eligible, the eye with the highest CFT will be selected as the study eye.
Previous laser photocoagulation therapy within the last 6 months.
Previous anti-VEGF therapy (Avastin, Lucentis, Eylea, or any investigational anti-VEGF drug) within the last 3 months.
Previous subtenon*s or intravitreal triamcinolone injection within the last 6 months.
Steroid implants of any kind within the last 3 years.
Macular ischemia confirmed by fluorescein angiography.
Vitreoretinal traction or epiretinal membranes with the potential of macular structural damage and function loss, confirmed by OCT.
Other eye conditions affecting VA prognosis, including pre-existent (deep) amblyopia.
Any ocular surgery/intervention within last three months before enrollment.
Any ocular surgery/intervention anticipated during the course of the study.
Ocular opacities hampering adequate imaging of the posterior pole.
Poor control of DM with glycated hemoglobin (HbA1c) of * 86% in last 6 months.
Allergy to fluorescein or anti-VEGF, or any of its preservatives.
Pregnancy.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Proportion of failures to treatment at 72 weeks.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Visual acuity, central foveal thickness.</p><br>