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Completed

NCT Number: 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

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.

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Key information

Conditions

Retinal Disease Eye Diseases Retinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aflibercept (BAY86-5321, Eylea)

Drug

Intravitreal injection of aflibercept as scheduled by treating physician

Other names: Eylea®; Eylia®; Wetlia®; VEGF Trap-Eye

Primary outcomes

  1. Number of ocular adverse events

    Time frame: Up to 12 months

  2. Number of serious ocular adverse events

    Time frame: Up to 12 months

  3. 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.

  4. 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.

  5. Number of treatment-related ocular adverse events

    Time frame: Up to 12 months

  6. Number of injection-related ocular adverse events

    Time frame: Up to 12 months

  7. Action taken with drug after ocular adverse event

    Time frame: Up to 12 months

    Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed

  8. Clinical outcome of ocular adverse event

    Time frame: Up to 12 months

    Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown

  9. Duration of ocular adverse events

    Time frame: Up to 12 months

  10. Duration of patient follow-up after ocular adverse event (in months)

    Time frame: Up to 12 months

  11. Number of non-ocular adverse events

    Time frame: Up to 12 months

  12. Number of serious non-ocular adverse events

    Time frame: Up to 12 months

  13. 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.

  14. 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.

  15. Number of treatment-related non-ocular adverse events

    Time frame: Up to 12 months

  16. Number of injection-related non-ocular adverse events

    Time frame: Up to 12 months

  17. 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

  18. Clinical outcome of non-ocular adverse event

    Time frame: Up to 12 months

    Options: Resolved, Resolving, Resolved with sequelae, Not resolved, Fatal, Unknown

  19. Duration of non-ocular adverse events

    Time frame: Up to 12 months

  20. Duration of patient follow-up after non-ocular adverse event (in months)

    Time frame: Up to 12 months

Secondary outcomes

  1. Total number of injections with intravitreal aflibercept per study eye

    Time frame: Up to 12 months

  2. Time between injections in the study eye (in days)

    Time frame: Up to 12 months

  3. Time between injections in the study eye and fellow eye (in days)

    Time frame: Up to 12 months

  4. Number of patients receiving bilateral treatment

    Time frame: Up to 18 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study 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).

Acronym: MAIA

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 23, 2019
Registry last updated
Feb 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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