AURIGA: 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

Sponsor
Bayer (Industry)
Overall Status
Completed
CT.gov ID
NCT03161912
Collaborator
(none)
2,550
11
48.8
231.8
4.8

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Aflibercept (Eylea, BAY86-5321)

Study Design

Study Type:
Observational
Actual Enrollment :
2550 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 24, 2017
Actual Primary Completion Date :
Aug 31, 2021
Actual Study Completion Date :
Dec 17, 2021

Arms and Interventions

Arm Intervention/Treatment
DME/naïve

patients with pre-treatment in diabetic macular edema (DME)

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

DME/pre-treatment

patients without pre-treatment in DME

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

RVO/pre-treatment

Macular edema secondary to RVO with prior treatment

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

RVO/naïve

Macular edema secondary to RVO without prior treatment

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

Outcome Measures

Primary Outcome Measures

  1. Mean change of visual acuity (VA) from baseline to 12 months as evaluated in routine clinical practice per cohort and per country. [Baseline and at 12 months]

    Analysis will be done per cohort and country.

Secondary Outcome Measures

  1. Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment [Up to 24 months]

    Secondary endpoint based on a pooled analysis over all countries and cohorts.

  2. Number 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 [Up to 24 months]

    Analysis will be done per cohort and country.

  3. 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 [Up to 24 months]

    Analysis will be done per cohort and country.

  4. 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 [Up to 24 months]

    Analysis will be done per cohort and country.

  5. 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 [Up to 2 years]

    Analysis will be done per cohort and country.

  6. 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 [Up to 2 years]

    Analysis will be done per cohort and country. Including number of visits in clinics/ophthalmology practices other than the study center.

  7. Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period [Up to 2 years]

    Analysis will be done per cohort and country. The procedures contains: Slit lamp biomicroscopy Funduscopy examination Fluorescein angiographies

  8. 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) [Up to 2 years]

    Analysis will be done per cohort and country.

  9. Number of performed laser treatments [Up to 2 years]

    Analysis will be done per cohort and country.

  10. Treatment pattern based on mean time between visits and mean time between aflibercept injections [Up to 2 years]

    Analysis will be done per cohort and country.

  11. Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period. [Up to 2 years]

    Analysis will be done per cohort and country.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Many Locations Multiple Locations China
2 Many Locations Multiple Locations Egypt
3 Many Locations Multiple Locations France
4 Many Locations Multiple Locations Germany
5 Many Locations Multiple Locations Italy
6 Many Locations Multiple Locations Kuwait
7 Many Locations Multiple Locations Lebanon
8 Many Locations Multiple Locations Russian Federation
9 Many Locations Multiple Locations Saudi Arabia
10 Many Locations Multiple Locations Taiwan
11 Many Locations Multiple Locations United Arab Emirates

Sponsors and Collaborators

  • Bayer

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Bayer
ClinicalTrials.gov Identifier:
NCT03161912
Other Study ID Numbers:
  • 19157
First Posted:
May 22, 2017
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bayer
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 24, 2022