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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,481 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Macular Edema

Interventions

Type	Name	Description
DRUG	Aflibercept (Eylea, BAY86-5321)	As per the treating physicians discretion.

Timeline

• Start date: 2017-11-24
• Primary completion: 2021-09-14
• Completion: 2021-12-17
• First posted: 2017-05-22
• Last updated: 2022-11-14

Locations

11 sites across 11 countries: China, Egypt, France, Germany, Italy, Kuwait, Lebanon, Russia, Saudi Arabia, Taiwan, United Arab Emirates