NL-OMON39983
Completed
Not Applicable
The Most Effective Treatment Strategy for Diabetic Macular Edema. - METS for DME
Oogziekenhuis Rotterdam0 sites456 target enrollmentTBD
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- diabetic macular edema
- Sponsor
- Oogziekenhuis Rotterdam
- Enrollment
- 456
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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