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

Bayer911 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

911

Conditions

Ophthalmology Macular Edema Macular Degeneration

Interventions

Ranibizumab (or other DME treatment)DRUG

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

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (8)

Unnamed facility

Many Locations, France

Unnamed facility

Many Locations, Germany

Unnamed facility

Many Locations, Greece

Unnamed facility

Many Locations, Portugal

Outcomes

Primary Outcomes

Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN

Time frame: Baseline, after 12 months

Secondary Outcomes

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

Data from ClinicalTrials.gov

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