NCT04137120

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

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).

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 73 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DRUG	Aflibercept (BAY86-5321, Eylea)	Intravitreal injection of aflibercept as scheduled by treating physician

Timeline

• Start date: 2021-02-19
• Primary completion: 2022-08-17
• Completion: 2023-02-01
• First posted: 2019-10-23
• Last updated: 2023-02-17

Locations

1 site across 1 country: Mexico