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

Status

Completed

Conditions

Macular Edema

Treatments

Drug: Aflibercept (Eylea, BAY86-5321)

Study type

Observational

Funder types

Industry

Identifiers

NCT03161912

19157

Details and patient eligibility

About

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.

Enrollment

2,481 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.