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

19157

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.

2017-11-24

2021-09-14

2021-12-17

Completed

2481

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.

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 2481, 'type': 'ACTUAL'}}

2022-11-14