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

Retinal Disease Clinical Trial

— MAIA  

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04137120
• Other study ID #: 19212
• Status: Completed
• Start date: February 19, 2021
• Est. completion date: February 1, 2023

Study information

• Verified date: February 2023
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. Data will be collected from patients who are being treated for such eye disorders in Mexican routine clinical practice.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: February 1, 2023
• Est. primary completion date: August 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Edema
• Retinal Disease
• Retinal Diseases
• Retinal Vein Occlusion

Intervention

Drug:
• Aflibercept (BAY86-5321, Eylea)
Intravitreal injection of aflibercept as scheduled by treating physician

Locations

Country	Name	City	State
Mexico	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of ocular adverse events		Up to 12 months
Primary	Number of serious ocular adverse events		Up to 12 months
Primary	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
Primary	Severity of ocular adverse events	The severity of adverse events is classified as mild, moderate or severe by treating physician.	Up to 12 months
Primary	Number of treatment-related ocular adverse events		Up to 12 months
Primary	Number of injection-related ocular adverse events		Up to 12 months
Primary	Action taken with drug after ocular adverse event	Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed	Up to 12 months
Primary	Clinical outcome of ocular adverse event	Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown	Up to 12 months
Primary	Duration of ocular adverse events		Up to 12 months
Primary	Duration of patient follow-up after ocular adverse event (in months)		Up to 12 months
Primary	Number of non-ocular adverse events		Up to 12 months
Primary	Number of serious non-ocular adverse events		Up to 12 months
Primary	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
Primary	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
Primary	Number of treatment-related non-ocular adverse events		Up to 12 months
Primary	Number of injection-related non-ocular adverse events		Up to 12 months
Primary	Action taken with drug after non-ocular adverse event	Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed	Up to 12 months
Primary	Clinical outcome of non-ocular adverse event	Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown	Up to 12 months
Primary	Duration of non-ocular adverse events		Up to 12 months
Primary	Duration of patient follow-up after non-ocular adverse event (in months)		Up to 12 months
Secondary	Total number of injections with intravitreal aflibercept per study eye		Up to 12 months
Secondary	Time between injections in the study eye (in days)		Up to 12 months
Secondary	Time between injections in the study eye and fellow eye (in days)		Up to 12 months
Secondary	Number of patients receiving bilateral treatment		Up to 18 months