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

Macular Degeneration Clinical Trial

— POLARIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771081
• Other study ID #: 16459
• Secondary ID: NN1201
• Status: Completed
• Phase: N/A
• First received: January 11, 2013
• Last updated: October 27, 2015
• Start date: April 2013
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: National Board of Physicians (C.N.O.M "Comité National de l'Ordre des Médecins)Germany: Ethics CommitteeUK: UK Research Ethics Committee, UK National Health Service, Research and Development Department at each siteItaly: Ethics Committee, Italian Authority for Privacy and data Protection (Garante per la Privacy)Portugal:Ethics CommitteeRussia: Ethics CommitteeSpain: Ethics CommitteeSlovac Republic: Ethics CommitteeGreece: Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 911
• Est. completion date: April 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Edema
• Macular Degeneration
• Macular Edema
• Ophthalmology

Intervention

Drug:
• Ranibizumab (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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

France,  Germany,  Greece,  Portugal,  Russian Federation,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in visual acuity, assessed by Early Treatment Diabetic Retinopathy Study (ETDRS) or SNELLEN		Baseline, after 12 months	No
Secondary	Demographic and clinical characteristics (Age, sex, race, employment status, severity of DME)		Baseline	No
Secondary	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	No
Secondary	Changes in retinal thickness, measured by Optical Coherence Tomography (OCT)		Baseline, after 12 month	No
Secondary	Presence of clinically significant macular edema, measured as defined by the ETDRS Research Group		Baseline, after each month, up to 12 month	No
Secondary	Resource utilization in terms of treatment choices, frequency and duration		Baseline, after 6 and 12 months	No
Secondary	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	No

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