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NCT Number: NCT03161912

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 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.

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Key information

Conditions

Macular Edema Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Retinopathy Embolism and Thrombosis Endocrine System Diseases Eye Diseases Glucose Metabolism Disorders Macular Degeneration Metabolic Diseases Nutritional and Metabolic Diseases Retinal Degeneration Retinal Diseases Retinal Vein Occlusion Thrombosis Vascular Diseases Venous Thrombosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Aflibercept (Eylea, BAY86-5321)

Drug

As per the treating physicians discretion.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study 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

Acronym: AURIGA

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 22, 2017
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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