Trial Condition(s):
Ophthalmology, Macular Edema
Evaluation of changes in visual acuity in patients with diabetic macular edema (DME) starting treatment with an approved anti-VEGF therapy (POLARIS)
Bayer Identifier:
16459
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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.
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
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Germany | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, France | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Portugal | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Greece | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Russia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, Slovakia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Many Locations, United Kingdom | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLENTimeframe: Baseline, after 12 months
Secondary Outcome
- Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)Timeframe: Baseline
- Mean time from diagnosis to first commencement with an approved anti-VEGF therapyTimeframe: Date of first diagnosis; Date of treatment initiation: up to 24 month
- Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)Timeframe: Baseline, after 12 month
- Presence of clinically significant macular edema, measured as defined by the ETDRS Research GroupTimeframe: Baseline, after each month, up to 12 month
- Resource utilization in terms of treatment choices, frequency and durationTimeframe: 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 practiceTimeframe: Baseline, after 6 and 12 months
Additional Information
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