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

Macular Edema Clinical Trial

— AURIGA  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03161912
• Other study ID #: 19157
• Status: Completed
• Start date: November 24, 2017
• Est. completion date: December 17, 2021

Study information

• Verified date: November 2022
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2481
• Est. completion date: December 17, 2021
• Est. primary completion date: September 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

Drug:
• Aflibercept (Eylea, BAY86-5321)
As per the treating physicians discretion.

Locations

Country	Name	City	State
China	Many Locations	Multiple Locations
Egypt	Many Locations	Multiple Locations
France	Many Locations	Multiple Locations
Germany	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Kuwait	Many Locations	Multiple Locations
Lebanon	Many Locations	Multiple Locations
Russian Federation	Many Locations	Multiple Locations
Saudi Arabia	Many Locations	Multiple Locations
Taiwan	Many Locations	Multiple Locations
United Arab Emirates	Many Locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Countries where clinical trial is conducted

China,  Egypt,  France,  Germany,  Italy,  Kuwait,  Lebanon,  Russian Federation,  Saudi Arabia,  Taiwan,  United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change of visual acuity (VA) from baseline to 12 months as evaluated in routine clinical practice per cohort and per country.	Analysis will be done per cohort and country.	Baseline and at 12 months
Secondary	Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment	Secondary endpoint based on a pooled analysis over all countries and cohorts.	Up to 24 months
Secondary	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	Analysis will be done per cohort and country.	Up to 24 months
Secondary	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	Analysis will be done per cohort and country.	Up to 24 months
Secondary	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	Analysis will be done per cohort and country.	Up to 24 months
Secondary	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	Analysis will be done per cohort and country.	Up to 2 years
Secondary	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	Analysis will be done per cohort and country. Including number of visits in clinics/ophthalmology practices other than the study center.	Up to 2 years
Secondary	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		Up to 2 years
Secondary	Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period	Analysis will be done per cohort and country.; The procedures contains: Slit lamp biomicroscopy; Funduscopy examination; Fluorescein angiographies	Up to 2 years
Secondary	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)	Analysis will be done per cohort and country.	Up to 2 years
Secondary	Number of performed laser treatments	Analysis will be done per cohort and country.	Up to 2 years
Secondary	Treatment pattern based on mean time between visits and mean time between aflibercept injections	Analysis will be done per cohort and country.	Up to 2 years
Secondary	Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period.	Analysis will be done per cohort and country.	Up to 2 years