Study Completed

Macular Edema

Bayer Identifier:

19157

ClinicalTrials.gov Identifier:

NCT03161912

EudraCT Number:

Not Available

EU CT Number:

Not Available

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

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

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.

Trial summary

Enrollment Goal

2481

Trial Dates

November 2017 - December 2021

Phase

Phase 4

Could I Receive a placebo

Products

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many Locations	Many Locations, Germany
Completed	Many Locations	Many Locations, France
Completed	Many Locations	Many Locations, Italy
Completed	Many Locations	Many Locations, Russia
Completed	Many Locations	Many Locations, France
Completed	Many Locations	Many Locations, Taiwan
Completed	Many Locations	Many Locations, Egypt
Completed	Many Locations	Many Locations, Saudi Arabia
Completed	Many Locations	Many Locations, Lebanon
Completed	Many Locations	Many Locations, United Arab Emirates
Completed	Many Locations	Many Locations, Kuwait
Completed	Many Locations	Many Locations, China

Primary Outcome

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.
Time Frame:
Baseline and at 12 months

Secondary Outcome

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.
Time Frame:
Up to 24 months
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.
Time Frame:
Up to 24 months
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.
Time Frame:
Up to 24 months
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.
Time Frame:
Up to 24 months
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.
Time Frame:
Up to 2 years
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.
Time Frame:
Up to 2 years
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
Time Frame:
Up to 2 years
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
Time Frame:
Up to 2 years
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.
Time Frame:
Up to 2 years
Number of performed laser treatments
Analysis will be done per cohort and country.
Time Frame:
Up to 2 years
Treatment pattern based on mean time between visits and mean time between aflibercept injections
Analysis will be done per cohort and country.
Time Frame:
Up to 2 years
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.
Time Frame:
Up to 2 years

Trial design

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

Trial Type

Observational

Intervention Type

Drug

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A