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

NCT04137120 | Completed

• 1 other identifier: 19212
• Study Type: observational
• Target: 73
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Retinal Disease

Keywords

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); Mexico

Outcome Measures

Primary Outcomes (20)

• 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  Options: Withdrawn, Interrupted, Injection schedule changed, Injection schedule not changed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 Outcomes (4)

• 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

Study Arms (1)

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)

Interventions

Aflibercept (BAY86-5321, Eylea) DRUG

Intravitreal injection of aflibercept as scheduled by treating physician

Also known as: Eylea®; Eylia®; Wetlia®; VEGF Trap-Eye

Patients_Ocular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults with macular disease in Mexican routine practice

You may qualify if:

• 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);
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (1)

Many locations

Multiple Locations, Mexico

Location

MeSH Terms

Conditions

Retinal Diseases

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 23, 2019
• Study Start: February 19, 2021
• Primary Completion: August 17, 2022
• Study Completion: February 1, 2023
• Last Updated: February 17, 2023

Record last verified: 2023-02

Locations

ME (1)