Clinical trial NCT03161912: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Keywords: Diabetes
Retinal Diseases
Diabetic Retinopathy
Diabetic macular edema
Retinal vein occlusion
Macular edema secondary to retinal vein occlusion
Intravitreal anti-VEGF (vascular endothelial growth factor)
VEGF inhibitor
aflibercept
real world data
treatment pattern
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2017-05-22
Enrollment: 2481
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change of visual acuity (VA) from baseline to 12 months as evaluated in routine clinical practice per cohort and per country.
timeFrame: Baseline and at 12 months
Secondary outcomes:
measure: Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment
timeFrame: Up to 24 months
measure: 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 treatment
timeFrame: Up to 24 months
measure: 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 treatment
timeFrame: Up to 24 months
measure: 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 treatment
timeFrame: Up to 24 months
measure: 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 period
timeFrame: Up to 2 years
measure: 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 period
timeFrame: Up to 2 years
measure: 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 period
timeFrame: Up to 2 years
measure: Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period
timeFrame: Up to 2 years
measure: 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)
timeFrame: Up to 2 years
measure: Number of performed laser treatments
timeFrame: Up to 2 years
measure: Treatment pattern based on mean time between visits and mean time between aflibercept injections
timeFrame: Up to 2 years
measure: Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period.
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Multiple Locations
country: China
facility: Many Locations
city: Multiple Locations
country: Egypt
facility: Many Locations
city: Multiple Locations
country: France
facility: Many Locations
city: Multiple Locations
country: Germany
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Kuwait
facility: Many Locations
city: Multiple Locations
country: Lebanon
facility: Many Locations
city: Multiple Locations
country: Russian Federation
facility: Many Locations
city: Multiple Locations
country: Saudi Arabia
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
city: Multiple Locations
country: United Arab Emirates
facility: Many Locations
Study officials:
References: