Completed

AURIGAAn Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Cardiovascular Diseases+16

+ Diabetes Mellitus

+ Diabetic Angiopathies

Over 18 Years
See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: November 2017
See protocol details

Summary

Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: November 24, 2017

Actual date on which the first participant was enrolled.

AURIGA is designed to collect data from routine clinical practice on the effectiveness and utilization of intravitreal aflibercept in the treatment of visual impairment due to diabetic macular edema (DME) or macula edema secondary to retinal vein occlusion (RVO). The primary objective of this observational study (OS) is to evaluate the effectiveness of intravitreal aflibercept in 4 cohorts (with/without prior treatment in DME or macular edema secondary to RVO) in each of the participating countries. Additionally, utilization and treatment regimens in routine clinical practice will be described. Health care resources and services as well as health out-comes related to vision loss will be evaluated based on information collected using the AURIGA patient questionnaires.

Official TitleAn Observational Study Program to Investigate the Effectiveness of Intravitreal Aflibercept in Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion in a Real World Setting
Principal SponsorBayer
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

2481 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesDiabetes MellitusDiabetic AngiopathiesDiabetic RetinopathyEndocrine System DiseasesEye DiseasesMacular DegenerationMacular EdemaMetabolic DiseasesNutritional and Metabolic DiseasesRetinal DegenerationRetinal DiseasesRetinal Vein OcclusionThrombosisVascular DiseasesEmbolism and ThrombosisVenous ThrombosisGlucose Metabolism DisordersDiabetes Complications

Criteria

Inclusion Criteria: * For DME \-- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to DME * For macular edema secondary to RVO \-- Female and male patients of legal age, as defined by local regulations and local product labels, with visual impairment due to macular edema secondary to RVO * Patient for whom the decision to initiate treatment with aflibercept is made prior to and independent from study participation * Signed informed consent. Exclusion Criteria: * Any contraindications as listed in the local intravitreal aflibercept SmPC (summary of product characteristics) * Current participation in any other clinical (interventional) study or in any other anti-VEGF study * Receipt of systemic anti-VEGF and pro-VEGF treatment * Structural damage to the center of the macula in either eye that is likely to preclude improvement in VA following the resolution of macular edema or any other condition expected to permanently limit VA outcomes over the course of the study * Patients with prior retinal surgery * Any prior treatment with aflibercept * History of stroke or transient ischemic attacks within the last 6 months * Laser photocoagulation (panretinal or macular) in the study eye within 90 days of Day 1 * For patients with prior treatment (i.e. patients that previously have been treated with intravitreal anti-VEGF or steroids): * Previous treatment of the study eye with anti-angiogenic drugs or laser within the last 3 months and patients with ocular surgery of the study eye within the last 3 months * Intravitreal dexamethasone or triamcinolone in the study eye within the last 3 months * Fluocinolone implant within the last 3 years * Dexamethasone implant within the last 6 months * For DME \-- Concomitant therapy with any other agent to treat DME in the study eye. * For macular edema secondary to RVO * Patients who have received or who require pan retinal photocoagulation due to neovascularization * Concomitant therapy with any other agent to treat macular edema secondary to RVO in the study eye.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

Suspended

Many Locations

Multiple Locations, ChinaOpen Many Locations in Google Maps
Suspended

Many Locations

Multiple Locations, Egypt
Suspended

Many Locations

Multiple Locations, France
Suspended

Many Locations

Multiple Locations, Germany
Completed11 Study Centers