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Trial record 1 of 1 for:    NCT03161912
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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 (AURIGA)

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ClinicalTrials.gov Identifier: NCT03161912
Recruitment Status : Recruiting
First Posted : May 22, 2017
Last Update Posted : December 2, 2019
Sponsor:
Collaborator:
Regeneron Pharmaceuticals
Information provided by (Responsible Party):
Bayer

Tracking Information
First Submitted Date May 19, 2017
First Posted Date May 22, 2017
Last Update Posted Date December 2, 2019
Actual Study Start Date November 24, 2017
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 19, 2017)
Mean change of visual acuity (VA) from baseline to 12 months as evaluated in routine clinical practice per cohort and per country. [ Time Frame: Baseline and at 12 months ]
Analysis will be done per cohort and country.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03161912 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: December 10, 2017)
  • Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment [ Time Frame: Up to 24 months ]
    Secondary endpoint based on a pooled analysis over all countries and cohorts.
  • 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 [ Time Frame: Up to 24 months ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: Up to 24 months ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: Up to 24 months ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: 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.
  • Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country. The procedures contains:
    • Slit lamp biomicroscopy
    • Funduscopy examination
    • Fluorescein angiographies
  • 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) [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • Number of performed laser treatments [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • Treatment pattern based on mean time between visits and mean time between aflibercept injections [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • Mean change in VA by number of injections during the first 6 months, the first year, and the 2-year treatment period. [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
Original Secondary Outcome Measures
 (submitted: May 19, 2017)
  • Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment [ Time Frame: Up to 24 months ]
    Secondary endpoint based on a pooled analysis over all countries and cohorts.
  • 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 [ Time Frame: Up to 24 months ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: Up to 24 months ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: Up to 24 months ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • 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 [ Time Frame: 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.
  • Number of procedures per patient during the first 6 months, the first year, and the 2-year treatment period [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country. The procedures contains:
    • Slit lamp biomicroscopy
    • Funduscopy examination
    • Fluorescein angiographies
  • 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) [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • Number of performed laser treatments [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
  • Treatment pattern based on mean time between visits and mean time between aflibercept injections [ Time Frame: Up to 2 years ]
    Analysis will be done per cohort and country.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Macular Edema
Intervention Drug: Aflibercept (Eylea, BAY86-5321)
As per the treating physicians discretion
Study Groups/Cohorts
  • DME/naïve
    patients with pre-treatment in diabetic macular edema (DME)
    Intervention: Drug: Aflibercept (Eylea, BAY86-5321)
  • DME/pre-treatment
    patients without pre-treatment in DME
    Intervention: Drug: Aflibercept (Eylea, BAY86-5321)
  • RVO/pre-treatment
    Macular edema secondary to RVO with prior treatment
    Intervention: Drug: Aflibercept (Eylea, BAY86-5321)
  • RVO/naïve
    Macular edema secondary to RVO without prior treatment
    Intervention: Drug: Aflibercept (Eylea, BAY86-5321)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 28, 2018)
3560
Original Estimated Enrollment
 (submitted: May 19, 2017)
2050
Estimated Study Completion Date June 30, 2021
Estimated Primary Completion Date March 31, 2021   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Bayer Clinical Trials Contact (+) 1-888-8422937 clinical-trials-contact@bayer.com
Contact: For trial location information (Phone Menu Options '3' or '4') (+)1-888-84 22937
Listed Location Countries China,   Egypt,   France,   Germany,   Italy,   Kuwait,   Lebanon,   Russian Federation,   Saudi Arabia,   Taiwan,   United Arab Emirates
Removed Location Countries  
 
Administrative Information
NCT Number NCT03161912
Other Study ID Numbers 19157
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Bayer
Study Sponsor Bayer
Collaborators Regeneron Pharmaceuticals
Investigators Not Provided
PRS Account Bayer
Verification Date November 2019