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

Sponsor
Bayer
Study ID
NCT03161912
Status
Completed

Conditions

  • Macular Edema

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 24, 2017
Status verified
Nov 2022
Primary completion
Sep 14, 2021
Completion
Dec 17, 2021

Study Design

Enrollment
2,481 participants (actual)

Arms

  • Arm: DME/naïve
    patients with pre-treatment in diabetic macular edema (DME)
  • Arm: DME/pre-treatment
    patients without pre-treatment in DME
  • Arm: RVO/pre-treatment
    Macular edema secondary to RVO with prior treatment
  • Arm: RVO/naïve
    Macular edema secondary to RVO without prior treatment

Primary Outcome Measure

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 ]

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