Clinical trial NCT01771081: Evaluation of Changes in Visual Acuity in Patients With Diabetic Macular Edema (DME) Starting Treatment With an Approved Anti-VEGF Therapy
Official title: 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
Overall status: COMPLETED
Conditions: Ophthalmology
Macular Edema
Macular Degeneration
Keywords: Longitudinal Studies,
Observation
Epidemiology
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2013-01-18
Enrollment: 911
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Sampling method: PROBABILITY_SAMPLE
Study population: In- and outpatients at participating sites with a diagnosis of DME with central involvement. Patients will be enrolled after the decision for treatment with an approved anti-VEGF therapy has been made at or after October 2012 by the study physician.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN
timeFrame: Baseline, after 12 months
Secondary outcomes:
measure: Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)
timeFrame: Baseline
measure: Mean time from diagnosis to first commencement with an approved anti-VEGF therapy
timeFrame: Date of first diagnosis; Date of treatment initiation: up to 24 month
measure: Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)
timeFrame: Baseline, after 12 month
measure: Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group
timeFrame: Baseline, after each month, up to 12 month
measure: Resource utilization in terms of treatment choices, frequency and duration
timeFrame: Baseline, after 6 and 12 months
measure: Mean change in quality of life score (using the NEI VFQ 25), only in countries where used as part of routine practice
timeFrame: Baseline, after 6 and 12 months
Other outcomes:
Locations:
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Greece
city: Many Locations
country: Portugal
city: Many Locations
country: Russian Federation
city: Many Locations
country: Slovakia
city: Many Locations
country: Spain
city: Many Locations
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: