Retinal DiseaseMAIANCT04137120
Study to Gather Information on the Safety and Use of Aflibercept Injections Into the Eye for the Treatment of Eye Disorders in Mexican Routine Clinical Practice
An observational study of Retinal Disease, run by Bayer at 1 site in Mexico.
Trial summary
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Retinal Disease
- What is being tested?
- Aflibercept (BAY86-5321, Eylea)
- Type of treatment
- Injection or infusion
- How many people
- 73 participants
- Where
- 1 siteMexico
- Study dates
- 19 Feb 2021to 1 Feb 2023
- 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: Adults with macular disease in Mexican routine practice
Who may be able to join
- Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV);
- Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
- Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
- If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Who cannot join
- Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
- Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
- Current treatment with other intravitreal therapies
- Contra-indications according to Eylea's / Wetlia's local marketing authorization:
- Ocular or periocular infection
- Active intraocular Inflammation
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- Known hypersensitivity to aflibercept or to any of its excipients
- Pregnant or lactating women.
- Participation in an interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of the Safety and Drug Utilization of Intravitreal Aflibercept Injection in Mexican Routine Clinical Practice for the Treatment of Wet Age Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO), Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) and Myopic Neovascularization (mCNV). A Post-authorization Safety Study (PASS).
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.
Read the detailed description
The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO).
Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.
- Conditions
- Retinal Disease
- Being tested
- Aflibercept (BAY86-5321, Eylea)
- Keywords
- Aflibercept, Intravitreal injection, Ocular disease, Wet age-related macular degeneration (wAMD), Diabetic macular edema (DME), Macular edema secondary to central retinal vein occlusion (CRVO), Macular edema secondary to branch retinal vein occlusion (BRVO), Myopic choroidal neovascularization (mCNV), Mexico
- Medical subject headings
- Retinal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aflibercept (BAY86-5321, Eylea)Drug
Also called Eylea®; Eylia®; Wetlia®; VEGF Trap-Eye
Intravitreal injection of aflibercept as scheduled by treating physician
| Study group | Role | What they receive |
|---|---|---|
| Patients_Ocular disease | Adult patients treated for wet age-related macular degeneration (wAMD), or diabetic macular edema (DME), or macular edema secondary to central retinal vein occlusion (CRVO), or macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV) in routine clinical practice in Mexico (overall cohort) Receives: Drug: Aflibercept (BAY86-5321, Eylea) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ocular adverse events
Measured: Up to 12 months
Number of serious ocular adverse events
Measured: Up to 12 months
Seriousness reason for ocular adverse events
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Measured: Up to 12 months
Severity of ocular adverse events
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Measured: Up to 12 months
Number of treatment-related ocular adverse events
Measured: Up to 12 months
Number of injection-related ocular adverse events
Measured: Up to 12 months
Action taken with drug after ocular adverse event
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Measured: Up to 12 months
Clinical outcome of ocular adverse event
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Measured: Up to 12 months
Duration of ocular adverse events
Measured: Up to 12 months
Duration of patient follow-up after ocular adverse event (in months)
Measured: Up to 12 months
Number of non-ocular adverse events
Measured: Up to 12 months
Number of serious non-ocular adverse events
Measured: Up to 12 months
Seriousness reason for non-ocular adverse events
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Measured: Up to 12 months
Severity of non-ocular adverse events
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Measured: Up to 12 months
Number of treatment-related non-ocular adverse events
Measured: Up to 12 months
Number of injection-related non-ocular adverse events
Measured: Up to 12 months
Action taken with drug after non-ocular adverse event
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Measured: Up to 12 months
Clinical outcome of non-ocular adverse event
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Measured: Up to 12 months
Duration of non-ocular adverse events
Measured: Up to 12 months
Duration of patient follow-up after non-ocular adverse event (in months)
Measured: Up to 12 months
Secondary outcomes (4)
Total number of injections with intravitreal aflibercept per study eye
Measured: Up to 12 months
Time between injections in the study eye (in days)
Measured: Up to 12 months
Time between injections in the study eye and fellow eye (in days)
Measured: Up to 12 months
Number of patients receiving bilateral treatment
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start19 Feb 2021
- Primary completion17 Aug 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinal DiseaseStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137120
- Sponsor's protocol ID
- 19212
- Acronym
- MAIA
- Status last verified
- Feb 2023
- First submitted
- 22 Oct 2019
- Last updated
- 17 Feb 2023
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Safety and Drug Utilization of Intravitreal Aflibercept Injection in Mexican Routine Clinical Practice for the Treatment of Wet Age Related Macular Degeneration (wAMD), Diabetic Macular Edema (DME), Macular Edema Secondary to Central Retinal Vein Occlusion (CRVO), Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO) and Myopic Neovascularization (mCNV). A Post-authorization Safety Study (PASS).
- ClinicalTrials.gov ID
- NCT04137120
- Acronym / sponsor ID
- MAIA / 19212
- Conditions
- Retinal Disease
- Keywords
- Aflibercept, Intravitreal injection, Ocular disease, Wet age-related macular degeneration (wAMD), Diabetic macular edema (DME), Macular edema secondary to central retinal vein occlusion (CRVO), Macular edema secondary to branch retinal vein occlusion (BRVO), Myopic choroidal neovascularization (mCNV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2021 (actual)
- Primary completion
- 17 Aug 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 23 Oct 2019 (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.
The study aims to collect data on the safety and use of intravitreal aflibercept injections into the eye for the treatment of eye disorders that cause blurred vision or a blind spot due to abnormal or blocked blood vessels. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.
Detailed description
The primary objective is to assess the safety of intravitreal aflibercept injections in patients with wet age-related macular degeneration (wAMD), myopic choroidal neovascularization (mCNV), diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO) or macular edema secondary to branch retinal vein occlusion (BRVO).
Secondary objectives comprise the comparison of the aflibercept safety profile between defined subgroups and the assessment of the real-world application of intravitreal aflibercept injections with special focus on CRVO, BRVO and mCNV indications.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients_Ocular disease | – | Drug: Aflibercept (BAY86-5321, Eylea)Adult patients treated for wet age-related macular degeneration (wAMD), or diabetic macular edema (DME), or macular edema secondary to central retinal vein occlusion (CRVO), or macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV) in routine clinical practice in Mexico (overall cohort) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with macular disease in Mexican routine practice
Key inclusion criteria (4 listed)
- Adult patients with a diagnosis of a wet age-related macular degeneration (wAMD), diffuse diabetic macular edema (DME), macular edema secondary to central retinal vein occlusion (CRVO), macular edema secondary to branch retinal vein occlusion (BRVO) or myopic choroidal neovascularization (mCNV);
- Decision to initiate treatment with intravitreal aflibercept was made as per investigator's routine treatment practice and independently of study inclusion;
- Treatment naïve or pre-treated for macular diseases (to anti-VEGF and steroid intravitreal treatments); patients who underwent laser photocoagulation and/or are being treated with panretinal photocoagulation therapies are eligible for study participation;
- If of childbearing potential, female willing to use effective contraception during treatment and for at least 3 months after the last intravitreal injection of aflibercept
Key exclusion criteria (9 listed)
- Patient diagnosed with two or more of the studied indications in the same eye (wAMD, DME, CRVO, BRVO and mCNV);
- Patients that were already treated with anti-VEGF or steroids are allowed to be enrolled only if they received the last dose of anti-VEGF 3 or more months ago and in the case of a steroid implant 6 months after the last dose;
- Current treatment with other intravitreal therapies
- Contra-indications according to Eylea's / Wetlia's local marketing authorization:
- Participation in an interventional study
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 (BAY86-5321, Eylea)Also: Eylea®; Eylia®; Wetlia®; VEGF Trap-EyeIntravitreal injection of aflibercept as scheduled by treating physician | Drug | Patients_Ocular disease |
Primary outcome
Number of ocular adverse events
Time frame: Up to 12 months
Number of serious ocular adverse events
Time frame: Up to 12 months
Seriousness reason for ocular adverse events
Time frame: Up to 12 months
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Severity of ocular adverse events
Time frame: Up to 12 months
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Number of treatment-related ocular adverse events
Time frame: Up to 12 months
Number of injection-related ocular adverse events
Time frame: Up to 12 months
Action taken with drug after ocular adverse event
Time frame: Up to 12 months
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Clinical outcome of ocular adverse event
Time frame: Up to 12 months
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Duration of ocular adverse events
Time frame: Up to 12 months
Duration of patient follow-up after ocular adverse event (in months)
Time frame: Up to 12 months
Number of non-ocular adverse events
Time frame: Up to 12 months
Number of serious non-ocular adverse events
Time frame: Up to 12 months
Seriousness reason for non-ocular adverse events
Time frame: Up to 12 months
Seriousness reasons may be death, life-threatening character of event, hospitalization or prolongation of hospitalization, congenital anomaly/ birth defect, persistent or significant impairment, or medical relevance of adverse event.
Severity of non-ocular adverse events
Time frame: Up to 12 months
The severity of adverse events is classified as mild, moderate or severe by treating physician.
Number of treatment-related non-ocular adverse events
Time frame: Up to 12 months
Number of injection-related non-ocular adverse events
Time frame: Up to 12 months
Action taken with drug after non-ocular adverse event
Time frame: Up to 12 months
Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed
Clinical outcome of non-ocular adverse event
Time frame: Up to 12 months
Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown
Duration of non-ocular adverse events
Time frame: Up to 12 months
Duration of patient follow-up after non-ocular adverse event (in months)
Time frame: Up to 12 months
4 secondary outcomes
Total number of injections with intravitreal aflibercept per study eye
Time frame: Up to 12 months
Time between injections in the study eye (in days)
Time frame: Up to 12 months
Time between injections in the study eye and fellow eye (in days)
Time frame: Up to 12 months
Number of patients receiving bilateral treatment
Time frame: Up to 18 months
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 17 Feb 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Retinal Disease, run by Bayer at 1 site in Mexico.
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 4 inclusion and 9 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 17 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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?
Number of ocular adverse events (time frame: Up to 12 months). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2023.