CompletedNot Applicable

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

France, Germany, Greece911 participantsStarted 2013-04

Plain-language 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.

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline, after 12 months

Trial details

NCT IDNCT01771081

SponsorBayer

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2015-01

View on ClinicalTrials.gov More Ophthalmology trials

Who can participate

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.