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

NCT03161912 | Completed

• 1 other identifier: 19157
• Study Type: observational
• Target: 2,481
• Locations: 11 countries
• Sites: 11

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment

  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

  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

  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

  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

  Up to 2 years

Study Arms (4)

DME/naïve

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

Drug: Aflibercept (Eylea, BAY86-5321)

DME/pre-treatment

patients without pre-treatment in DME

Drug: Aflibercept (Eylea, BAY86-5321)

RVO/pre-treatment

Macular edema secondary to RVO with prior treatment

Drug: Aflibercept (Eylea, BAY86-5321)

RVO/naïve

Macular edema secondary to RVO without prior treatment

Drug: Aflibercept (Eylea, BAY86-5321)

Interventions

Aflibercept (Eylea, BAY86-5321) DRUG

As per the treating physicians discretion.

DME/naïve; DME/pre-treatment; RVO/naïve; RVO/pre-treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (11)

Many Locations

Multiple Locations, China

Location

Many Locations

Multiple Locations, Egypt

Location

Many Locations

Multiple Locations, France

Location

Many Locations

Multiple Locations, Germany

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Kuwait

Location

Many Locations

Multiple Locations, Lebanon

Location

Many Locations

Multiple Locations, Russia

Location

Many Locations

Multiple Locations, Saudi Arabia

Location

Many Locations

Multiple Locations, Taiwan

Location

Many Locations

Multiple Locations, United Arab Emirates

Location

Related Publications (2)

• Donati S, Yang CH, Xu X, Mura M, Giocanti-Auregan A, Hoerauf H, Allmeier H, Machewitz T, Johnson KT, Santoro E; AURIGA study investigators. Intravitreal Aflibercept for the Treatment of Diabetic Macular Edema in Routine Clinical Practice: Results from the 24-Month AURIGA Observational Study. Ophthalmol Ther. 2024 Jan;13(1):161-178. doi: 10.1007/s40123-023-00829-3. Epub 2023 Nov 4.

  PMID: 37924483 DERIVED

• Giocanti-Auregan A, Donati S, Hoerauf H, Allmeier H, Rittenhouse KD, Machewitz T, Yang CH; AURIGA Study Investigators. Real-World Management of Macular Edema Secondary to Retinal Vein Occlusion with Intravitreal Aflibercept: 24-month Results from the AURIGA Observational Study. Ophthalmol Ther. 2024 Jan;13(1):179-203. doi: 10.1007/s40123-023-00830-w. Epub 2023 Nov 4.

  PMID: 37924481 DERIVED

MeSH Terms

Conditions

Macular Edema; Diabetes Mellitus; Retinal Diseases; Diabetic Retinopathy; Retinal Vein Occlusion

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Eye Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Venous Thrombosis; Thrombosis; Embolism and Thrombosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: May 22, 2017
• Study Start: November 24, 2017
• Primary Completion: September 14, 2021
• Study Completion: December 17, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

LE (1); TW (1); EG (1); CN (1); SA (1); KU (1); IT (1); RU (1); AE (1); DE (1); FR (1)