Macular EdemaAURIGANCT03161912
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
An observational study of Macular Edema, run by Bayer at 11 sites in 11 countries.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Macular Edema
- What is being tested?
- Aflibercept (Eylea, BAY86-5321)
- How many people
- 2,481 participants
- Where
- 11 sitesin 11 countries
- Study dates
- 24 Nov 2017to 17 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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 locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
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
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.
Read more
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
- Being tested
- Aflibercept (Eylea, BAY86-5321)
- 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
- Medical subject headings
- Macular Edema, Diabetes Mellitus, Retinal Diseases, Diabetic Retinopathy, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (Eylea, BAY86-5321)Drug
As per the treating physicians discretion.
| Study group | Role | What they receive |
|---|---|---|
| DME/naïve | patients with pre-treatment in diabetic macular edema (DME) Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| DME/pre-treatment | patients without pre-treatment in DME Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| RVO/pre-treatment | Macular edema secondary to RVO with prior treatment Receives: Drug: Aflibercept (Eylea, BAY86-5321) | |
| RVO/naïve | Macular edema secondary to RVO without prior treatment Receives: Drug: Aflibercept (Eylea, BAY86-5321) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and at 12 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 2 years
Number of performed laser treatments
Analysis will be done per cohort and country.
Measured: 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.
Measured: 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.
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study start24 Nov 2017
- Primary completion14 Sep 2021
- Study completion17 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Macular EdemaStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,481 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03161912
- Sponsor's protocol ID
- 19157
- Acronym
- AURIGA
- Status last verified
- Nov 2022
- First submitted
- 19 May 2017
- Last updated
- 14 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Publications
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.
PubMed 37924483Giocanti-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.
PubMed 37924481
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03161912
- Acronym / sponsor ID
- AURIGA / 19157
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,481 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- 14 Sep 2021 (actual)
- Study completion
- 17 Dec 2021 (actual)
- First posted
- 22 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DME/naïve | – | Drug: Aflibercept (Eylea, BAY86-5321)patients with pre-treatment in diabetic macular edema (DME) |
| DME/pre-treatment | – | Drug: Aflibercept (Eylea, BAY86-5321)patients without pre-treatment in DME |
| RVO/pre-treatment | – | Drug: Aflibercept (Eylea, BAY86-5321)Macular edema secondary to RVO with prior treatment |
| RVO/naïve | – | Drug: Aflibercept (Eylea, BAY86-5321)Macular edema secondary to RVO without prior treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aflibercept (Eylea, BAY86-5321)As per the treating physicians discretion. | Drug | DME/naïve, DME/pre-treatment, RVO/naïve, RVO/pre-treatment |
Primary outcome
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.
12 secondary outcomes
Mean change of visual acuity from baseline to 6, 12 and 24 months after first treatment
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
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
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
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
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
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
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)
Time frame: Up to 2 years
Number of performed laser treatments
Time frame: Up to 2 years
Treatment pattern based on mean time between visits and mean time between aflibercept injections
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.
Time frame: Up to 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2022.
- Derived from this study: PubMed 37924483Donati 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.
- Derived from this study: PubMed 37924481Giocanti-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.
- Individual participant dataSharing planned: Undecided. Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Edema, run by Bayer at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China, Egypt, France, Germany, Italy and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03161912, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2022.