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)

• ClinicalTrials.gov Identifier: NCT03161912
• Recruitment Status: Completed
• First Posted: May 22, 2017
• Last Update Posted: November 14, 2022
• Sponsor: Bayer
• Collaborator: Regeneron Pharmaceuticals
• Information provided by (Responsible Party): Bayer

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Macular Edema	Drug: Aflibercept (Eylea, BAY86-5321)

Study Design

• Study Type: Observational
• Actual Enrollment: 2481 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: 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
• Actual Study Start Date: November 24, 2017
• Actual Primary Completion Date: September 14, 2021
• Actual Study Completion Date: December 17, 2021

Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

1. Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment [ Time Frame: Up to 24 months ]
   Secondary endpoint based on a pooled analysis over all countries and cohorts.
2. 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 [ Time Frame: Up to 24 months ]
   Analysis will be done per cohort and country.
3. 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 [ Time Frame: Up to 24 months ]
   Analysis will be done per cohort and country.
4. 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 [ Time Frame: Up to 24 months ]
   Analysis will be done per cohort and country.
5. 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 [ Time Frame: Up to 2 years ]
   Analysis will be done per cohort and country.
6. 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 [ Time Frame: Up to 2 years ]
   Analysis will be done per cohort and country. Including number of visits in clinics/ophthalmology practices other than the study center.
7. 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 [ Time Frame: Up to 2 years ]
8. Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period [ Time Frame: Up to 2 years ]

   Analysis will be done per cohort and country.

   The procedures contains:

   • Slit lamp biomicroscopy
   • Funduscopy examination
   • Fluorescein angiographies
9. 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) [ Time Frame: Up to 2 years ]
   Analysis will be done per cohort and country.
10. Number of performed laser treatments [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
11. Treatment pattern based on mean time between visits and mean time between aflibercept injections [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
12. Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period. [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• 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.

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.

Contacts and Locations

Locations

China

Many Locations

Multiple Locations, China

Egypt

Many Locations

Multiple Locations, Egypt

France

Many Locations

Multiple Locations, France

Germany

Many Locations

Multiple Locations, Germany

Italy

Many Locations

Multiple Locations, Italy

Kuwait

Many Locations

Multiple Locations, Kuwait

Lebanon

Many Locations

Multiple Locations, Lebanon

Russian Federation

Many Locations

Multiple Locations, Russian Federation

Saudi Arabia

Many Locations

Multiple Locations, Saudi Arabia

Taiwan

Many Locations

Multiple Locations, Taiwan

United Arab Emirates

Many Locations

Multiple Locations, United Arab Emirates

Sponsors and Collaborators

Bayer

Regeneron Pharmaceuticals

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT03161912
• Other Study ID Numbers: 19157
• First Posted: May 22, 2017
• Last Update Posted: November 14, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• 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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Bayer:

Diabetes; Retinal Diseases; Diabetic Retinopathy; Diabetic macular edema; Retinal vein occlusion; Macular edema secondary to retinal vein occlusion; Intravitreal anti-VEGF (vascular endothelial growth factor); VEGF inhibitor; aflibercept; real world data; treatment pattern

Additional relevant MeSH terms:

Macular Edema; Retinal Vein Occlusion; Edema; Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Aflibercept; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Physiological Effects of Drugs; Growth Inhibitors; Antineoplastic Agents