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.

Female and male patients of legal age with a diagnosis of DME or macular edema following RVO will be enrolled in eye clinics and ophthalmology practices after the decision for treatment with aflibercept has been made by the treating physician.

Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.