A Study to Evaluate the Effectiveness of Intravitreal Aflibercept in Patients With Diabetic Macular Edema and/or Macular Edema Secondary to Retinal Vein Occlusion, Which Either Have or Have Not Been Pretreated for Their Disease (AURIGA)

An 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

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.

Study Overview

• Status: Completed
• Conditions: Macular Edema
• Intervention / Treatment: Drug: Aflibercept (Eylea, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 2481

Contacts and Locations

Study Locations

• China
  • Multiple Locations, China
    • Many Locations
• Egypt
  • Multiple Locations, Egypt
    • Many Locations
• France
  • Multiple Locations, France
    • Many Locations
• Germany
  • Multiple Locations, Germany
    • Many Locations
• Italy
  • Multiple Locations, Italy
    • Many Locations
• Kuwait
  • Multiple Locations, Kuwait
    • Many Locations
• Lebanon
  • Multiple Locations, Lebanon
    • Many Locations
• Russian Federation
  • Multiple Locations, Russian Federation
    • Many Locations
• Saudi Arabia
  • Multiple Locations, Saudi Arabia
    • Many Locations
• Taiwan
  • Multiple Locations, Taiwan
    • Many Locations
• United Arab Emirates
  • Multiple Locations, United Arab Emirates
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Female and male patients of legal age with a diagnosis of DME or macular edema following RVO will be enrolled in eye clinics and ophthalmology practices after the decision for treatment with aflibercept has been made by the treating physician.

Description

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DME/naïve; patients with pre-treatment in diabetic macular edema (DME)	Drug: Aflibercept (Eylea, BAY86-5321); As per the treating physicians discretion.
DME/pre-treatment; patients without pre-treatment in DME	Drug: Aflibercept (Eylea, BAY86-5321); As per the treating physicians discretion.
RVO/pre-treatment; Macular edema secondary to RVO with prior treatment	Drug: Aflibercept (Eylea, BAY86-5321); As per the treating physicians discretion.
RVO/naïve; Macular edema secondary to RVO without prior treatment	Drug: Aflibercept (Eylea, BAY86-5321); As per the treating physicians discretion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of visual acuity (VA) from baseline to 12 months as evaluated in routine clinical practice per cohort and per country.	Analysis will be done per cohort and country.	Baseline and at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment	Secondary endpoint based on a pooled analysis over all countries and cohorts.	Up to 24 months
Percentage of study eyes with pre-determined VA gains and losses (equivalent to 5, 10 and 15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters closest to the visit 6, 12 and 24 months after first treatment	Analysis will be done per cohort and country.	Up to 24 months
Mean change from baseline in central retinal thickness (CRT) as measured with optical coherence tomography (OCT) to closest to the visit 6, 12 and 24 months after first treatment	Analysis will be done per cohort and country.	Up to 24 months
Proportion of study eyes with no fluid persistence as measured by spectral domain OCT (SD-OCT) closest to the visit 6, 12, and 24 months after first treatment	Analysis will be done per cohort and country.	Up to 24 months
Treatment pattern based on the number of intravitreal aflibercept injections in the study eye during the first 6 months, the first year, and the 2-year treatment period	Analysis will be done per cohort and country.	Up to 2 years
Mean number of visits regarding the study eye by type of visit during the first 6 months, the first year, and the 2-year treatment period	Analysis will be done per cohort and country. Including number of visits in clinics/ophthalmology practices other than the study center.	Up to 2 years
Number of visits regarding the study eye in clinics/ophthalmology practices other than the study center during the first 6 months, the first year, and the 2-year treatment period		Up to 2 years
Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period	Analysis will be done per cohort and country. The procedures contains: Slit lamp biomicroscopy; Funduscopy examination; Fluorescein angiographies	Up to 2 years
Number of patients requiring additional drug treatment and what category of drug (patients switching to steroid treatment only or to other anti-VEGFs are excluded)	Analysis will be done per cohort and country.	Up to 2 years
Number of performed laser treatments	Analysis will be done per cohort and country.	Up to 2 years
Treatment pattern based on mean time between visits and mean time between aflibercept injections	Analysis will be done per cohort and country.	Up to 2 years
Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period.	Analysis will be done per cohort and country.	Up to 2 years

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2017
• Primary Completion (Actual): September 14, 2021
• Study Completion (Actual): December 17, 2021

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Diabetes; Diabetic macular edema; Diabetic Retinopathy; real world data; Retinal Diseases; aflibercept; Retinal vein occlusion; treatment pattern; VEGF inhibitor; Macular edema secondary to retinal vein occlusion; Intravitreal anti-VEGF (vascular endothelial growth factor)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 19157

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No