Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Ophthalmology, Macular Edema, Macular Degeneration

Intervention / Treatment
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* Drug: Ranibizumab (or other DME treatment)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group1<br> | Drug: Ranibizumab (or other DME treatment)<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN |  | Baseline, after 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME) |  | Baseline | 
| Mean time from diagnosis to first commencement with an approved anti-VEGF therapy |  | Date of first diagnosis; Date of treatment initiation: up to 24 month | 
| Changes in retinal thickness, measured by Optical Coherence Tomography (OCT) |  | Baseline, after 12 month | 
| Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group |  | Baseline, after each month, up to 12 month | 
| Resource utilization in terms of treatment choices, frequency and duration |  | 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 |  | Baseline, after 6 and 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Longitudinal Studies,, Observation, Epidemiology