Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy
Overview
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.
Full Title of Study: “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”
Study Type
- Study Type: Observational
- Study Design
- Study Primary Completion Date: January 2015
Interventions
- Drug: Ranibizumab (or other DME treatment)
- Patients 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
Arms, Groups and Cohorts
- Group1
Clinical Trial Outcome Measures
Primary Measures
- Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
- Time Frame: Baseline, after 12 months
Secondary Measures
- Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)
- Time Frame: Baseline
- Mean time from diagnosis to first commencement with an approved anti-VEGF therapy
- Time Frame: Date of first diagnosis; Date of treatment initiation: up to 24 month
- Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)
- Time Frame: Baseline, after 12 month
- Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group
- Time Frame: Baseline, after each month, up to 12 month
- Resource utilization in terms of treatment choices, frequency and duration
- Time Frame: Baseline, after 6 and 12 months
- Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practice
- Time Frame: Baseline, after 6 and 12 months
Participating in This Clinical Trial
Inclusion Criteria
- Patients diagnosed with type 1 or 2 diabetes mellitus – Patients diagnosed with DME with central involvement (defined as the area of the center subfield of optical coherence tomography [OCT]) – Patients for whom the decision has been made to treat with an approved anti-VEGF therapy prior to inclusion into the study – Patients who received the first approved intravitreal anti VEGF treatment from October 01, 2012 – Patients who give informed consent in writing for study participation Exclusion Criteria:
- Treatment with any anti-VEGF therapy prior to the start of the observation period (October 01, 2012) or enrolment into the study – Participation in an investigational program with interventions out of clinical routine practice
Gender Eligibility: All
Minimum Age: N/A
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Bayer
- Collaborator
- Regeneron Pharmaceuticals
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Bayer Study Director, Study Director, Bayer
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