Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy
- Sponsor
- Bayer
- Study ID
- NCT01771081
- Status
- Completed
Conditions
- Macular Degeneration
- Macular Edema
- Ophthalmology
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Ranibizumab (or other DME treatment) — DRUGPatients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment
Study Details
POLARIS : A non-interventional study in patients with diabetic macular edema (DME) with central involvement to assess the effectiveness of existing anti-vascular endothelial growth factor (anti-VEGF) treatment regimens.
Key Dates
- First listed
- Jan 18, 2013
- Start date
- Apr 30, 2013
- Status verified
- Oct 2015
- Primary completion
- Jan 31, 2015
- Completion
- Apr 30, 2015
Study Design
- Enrollment
- 911 participants (actual)
Arms
- Arm: Group1
Primary Outcome Measure
Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN [ Time Frame: Baseline, after 12 months ]
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