Trial Condition(s):

Macular Edema

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)

Bayer Identifier:

19157

ClinicalTrials.gov Identifier:

NCT03161912

EudraCT Number:

Not Available

Study Completed

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.

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.

Trial Summary

Enrollment Goal
2481
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many Locations

Many Locations, Germany

Status
Completed
 
Locations

Many Locations

Many Locations, France

Status
Completed
 
Locations

Many Locations

Many Locations, Italy

Status
Completed
 
Locations

Many Locations

Many Locations, Russia

Status
Completed
 
Locations

Many Locations

Many Locations, Taiwan, China

Status
Completed
 
Locations

Many Locations

Many Locations, Egypt

Status
Completed
 
Locations

Many Locations

Many Locations, Saudi Arabia

Status
Completed
 
Locations

Many Locations

Many Locations, Lebanon

Status
Completed
 
Locations

Many Locations

Many Locations, United Arab Emirates

Status
Completed
 
Locations

Many Locations

Many Locations, Kuwait

Status
Completed
 
Locations

Many Locations

Many Locations, China

Status
Completed
 

Trial Design