The Most Effective Treatment Strategy for Diabetic Macular Edema.
Suspended
- Conditions
- Diabetic macular edema
- Registration Number
- NL-OMON25771
- Lead Sponsor
- The Rotterdam Eye Hospital / Rotterdam Ophthalmic InstitutePO Box 70030, NL-3000 LM Rotterdam
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Suspended
- Sex
- Not specified
- Target Recruitment
- 456
Inclusion Criteria
1. Age ¡Ý 18 years;
2. Able to read and sign the written informed consent;
Exclusion Criteria
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;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of treatment failures at 72 weeks, with treatment failure defined at 24 weeks as < 50 micron decrease in CFT and no improvement in VA, i.e. 1 or more letters loss in VA, compared to baseline. After the 24 week visit failure of treatment is defined as > 50 micron increase in CFT, irrespective of VA, compared to week 24.
- Secondary Outcome Measures
Name Time Method