check_circleStudy Completed
Ophthalmology, Macular Edema, Macular Degeneration
Bayer Identifier:
16459
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Evaluation of changes in visual acuity in patients with diabetic macular edema (DME) starting treatment with an approved anti-VEGF therapy
Trial purpose
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 Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
911Trial Dates
April 2013 - April 2015Phase
N/ACould I Receive a placebo
NoProducts
UnspecifiedAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Germany | |
Completed | Many Locations, France | |
Withdrawn | Many Locations, Italy | |
Completed | Many Locations, Spain | |
Completed | Many Locations, Portugal | |
Completed | Many Locations, Greece | |
Completed | Many Locations, Russia | |
Completed | Many Locations, Slovakia | |
Completed | Many Locations, United Kingdom |
Primary Outcome
- Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLENdate_rangeTime Frame:Baseline, after 12 monthsenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)date_rangeTime Frame:Baselineenhanced_encryptionNoSafety Issue:
- Mean time from diagnosis to first commencement with an approved anti-VEGF therapydate_rangeTime Frame:Date of first diagnosis; Date of treatment initiation: up to 24 monthenhanced_encryptionNoSafety Issue:
- Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)date_rangeTime Frame:Baseline, after 12 monthenhanced_encryptionNoSafety Issue:
- Presence of clinically significant macular edema, measured as defined by the ETDRS Research Groupdate_rangeTime Frame:Baseline, after each month, up to 12 monthenhanced_encryptionNoSafety Issue:
- Resource utilization in terms of treatment choices, frequency and durationdate_rangeTime Frame:Baseline, after 6 and 12 monthsenhanced_encryptionNoSafety Issue:
- Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practicedate_rangeTime Frame:Baseline, after 6 and 12 monthsenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A