The Impact of Baseline Visual Acuity on the Treatment Outcomes in Patients Treated With AflIbercept in Real-life Clinical Setting

NCT ID: NCT03278262

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2312 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-01

Study Completion Date

2017-12-31

Brief Summary

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The study will assess the mean change in Visual Acuity (VA) (overall and stratified by baseline VA) at year 1 and 2 of treatment with Aflibercept in real-life setting.

In addition, the study will ascertain the baseline VA in treatment -naïve Wet Age-Related Macular Degeneration or neo-vascular AMD (wAMD) patients who start treatment with Aflibercept in a real-life setting and it will assess the impact of baseline VA on the outcomes of Aflibercept treatment.

Detailed Description

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Conditions

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Wet Macular Degeneration

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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>= 70 letters

Baseline VA \>= 70 letters

Aflibercept (Eylea, BAY86-5321)

Intervention Type DRUG

Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.

36-69 letters

Baseline VA 36-69 letters

Aflibercept (Eylea, BAY86-5321)

Intervention Type DRUG

Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.

<=35 letters

Baseline VA \<=35 letters

Aflibercept (Eylea, BAY86-5321)

Intervention Type DRUG

Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.

Interventions

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Aflibercept (Eylea, BAY86-5321)

Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Treatment-naïve eyes with neovascularization AMD, with the indication to be treated with Aflibercept. One and/or two eyes per patient.

Exclusion Criteria

* Eyes treated previously with another anti-VEGF drug.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Many locations

Lund, , Sweden

Site Status

Countries

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Sweden

Related Links

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https://clinicaltrials.bayer.com/

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Other Identifiers

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19473

Identifier Type: -

Identifier Source: org_study_id

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