check_circleStudy Completed
Macular Edema
Bayer Identifier:
19157
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial purpose
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.
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 Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
2481Trial Dates
November 2017 - December 2021Phase
Phase 4Could I Receive a placebo
NoProducts
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations | Many Locations, Germany |
Completed | Many Locations | Many Locations, France |
Completed | Many Locations | Many Locations, Italy |
Completed | Many Locations | Many Locations, Russia |
Completed | Many Locations | Many Locations, France |
Completed | Many Locations | Many Locations, Taiwan |
Completed | Many Locations | Many Locations, Egypt |
Completed | Many Locations | Many Locations, Saudi Arabia |
Completed | Many Locations | Many Locations, Lebanon |
Completed | Many Locations | Many Locations, United Arab Emirates |
Completed | Many Locations | Many Locations, Kuwait |
Completed | Many Locations | Many Locations, China |
Primary Outcome
- 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.date_rangeTime Frame:Baseline and at 12 months
Secondary Outcome
- Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatmentSecondary endpoint based on a pooled analysis over all countries and cohorts.date_rangeTime Frame: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 treatmentAnalysis will be done per cohort and country.date_rangeTime Frame: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 treatmentAnalysis will be done per cohort and country.date_rangeTime Frame: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 treatmentAnalysis will be done per cohort and country.date_rangeTime Frame: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 periodAnalysis will be done per cohort and country.date_rangeTime Frame: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 periodAnalysis will be done per cohort and country. Including number of visits in clinics/ophthalmology practices other than the study center.date_rangeTime Frame: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 perioddate_rangeTime Frame:Up to 2 years
- Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment periodAnalysis will be done per cohort and country. The procedures contains: • Slit lamp biomicroscopy • Funduscopy examination • Fluorescein angiographiesdate_rangeTime Frame: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.date_rangeTime Frame:Up to 2 years
- Number of performed laser treatmentsAnalysis will be done per cohort and country.date_rangeTime Frame:Up to 2 years
- Treatment pattern based on mean time between visits and mean time between aflibercept injectionsAnalysis will be done per cohort and country.date_rangeTime Frame: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.date_rangeTime Frame:Up to 2 years
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A