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 (MAIA)

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.

Study Overview

• Status: Completed
• Conditions: Retinal Disease
• Intervention / Treatment: Drug: Aflibercept (BAY86-5321, Eylea)

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 Type: Observational
• Enrollment (Actual): 73

Contacts and Locations

Study Locations

• Mexico
  • Multiple Locations, Mexico
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with macular disease in Mexican routine practice

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
  • Known hypersensitivity to aflibercept or to any of its excipients
  • Pregnant or lactating women.
• Participation in an interventional study

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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)	Drug: Aflibercept (BAY86-5321, Eylea); Intravitreal injection of aflibercept as scheduled by treating physician; Other Names: Eylea®; Eylia®; Wetlia®; VEGF Trap-Eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of ocular adverse events		Up to 12 months
Number of serious ocular adverse events		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.	Up to 12 months
Severity of ocular adverse events	The severity of adverse events is classified as mild, moderate or severe by treating physician.	Up to 12 months
Number of treatment-related ocular adverse events		Up to 12 months
Number of injection-related ocular adverse events		Up to 12 months
Action taken with drug after ocular adverse event	Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed	Up to 12 months
Clinical outcome of ocular adverse event	Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown	Up to 12 months
Duration of ocular adverse events		Up to 12 months
Duration of patient follow-up after ocular adverse event (in months)		Up to 12 months
Number of non-ocular adverse events		Up to 12 months
Number of serious non-ocular adverse events		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.	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.	Up to 12 months
Number of treatment-related non-ocular adverse events		Up to 12 months
Number of injection-related non-ocular adverse events		Up to 12 months
Action taken with drug after non-ocular adverse event	Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed	Up to 12 months
Clinical outcome of non-ocular adverse event	Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown	Up to 12 months
Duration of non-ocular adverse events		Up to 12 months
Duration of patient follow-up after non-ocular adverse event (in months)		Up to 12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Total number of injections with intravitreal aflibercept per study eye	Up to 12 months
Time between injections in the study eye (in days)	Up to 12 months
Time between injections in the study eye and fellow eye (in days)	Up to 12 months
Number of patients receiving bilateral treatment	Up to 18 months

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): February 19, 2021
• Primary Completion (Actual): August 17, 2022
• Study Completion (Actual): February 1, 2023

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): February 17, 2023
• Last Update Submitted That Met QC Criteria: February 16, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Mexico; 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)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Retinal Diseases; Macular Edema; Retinal Vein Occlusion; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 19212

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No