Macular Degeneration, Macular Edema, Ophthalmology
Conditions
Keywords
Longitudinal Studies,, Observation, Epidemiology
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.
Interventions
DRUGRanibizumab (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
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN | Baseline, after 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME) | Baseline |
| 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 |
| Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group | Baseline, after each month, up to 12 month |
Countries
France, Germany, Greece, Portugal, Russia, Slovakia, Spain, United Kingdom
Outcome results
None listed