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). (MAIA)

  • STATUS
    Recruiting
  • days left to enroll
    64
  • participants needed
    69
  • sponsor
    Bayer
Updated on 19 September 2022

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.

Details
Condition Retinal Disease
Treatment Aflibercept (BAY86-5321, Eylea)
Clinical Study IdentifierNCT04137120
SponsorBayer
Last Modified on19 September 2022

Eligibility

Yes No Not Sure

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
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