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

Completed

• Conditions: Ophthalmology; Macular Edema; Macular Degeneration
• Interventions: Drug: Ranibizumab (or other DME treatment)

• Registration Number: NCT01771081
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-01-11
• Study First Submitted QC: 2013-01-16
• Study First Posted: 2013-01-18
• Study Start: 2013-04
• Primary Completion: 2015-01
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-27
• Last Update Posted: 2015-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 911

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group1	Ranibizumab (or other DME treatment)	-

Primary Outcome Measures

Name	Time	Method
Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN	Baseline, after 12 months

Secondary Outcome Measures

Name	Time	Method
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
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