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Observational Study to Assess Intravitreal Aflibercept Injections Used in a "Treat and Extend" Regimen in Treatment-naïve Wet Age-related Macular Degeneration Patients (ASTERIA)

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Bayer

Status

Completed

Conditions

Wet Age-related Macular Degeneration

Treatments

Drug: Aflibercept (Eylea, BAY86-5321)

Study type

Observational

Funder types

Industry

Identifiers

Details and patient eligibility

About

The purpose of this observational study lies in the analysis of a treat-and-extend injection scheme with intravitreal aflibercept (i.e. injection into the eye), as applied in routine practice in previously untreated patients diagnosed with wet age-related macular degeneration.

Full description

Data will be collected from the medical files retro- and prospectively. If patients are still under treatment at study initiation and have not yet completed 24 months of treatment with intravitreal aflibercept in a treat-and-extend regimen, data of the remaining observation period will be collected prospectively.

Enrollment

163 patients

Sex

All

Ages

55+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of wet age-related macular degeneration.
  • No prior therapy for wet age-related macular degeneration.
  • Patients for whom the decision to initiate treatment with IVT-AFL in a T&E regimen was made as per routine clinical practice.
  • Patient age >55 years of age

Exclusion criteria

  • Participation in an investigational program with therapeutical interventions outside of clinical routine practice.
  • Patients with eye diseases e.g. advanced glaucoma or visually significant cataracts, likely to require surgery during the observation period in the study eye.
  • Concomitant ocular or systemic administration of drugs up to 3 months before commencement of IVT-AFL treatment that could interfere with or potentiate the mechanism of action of aflibercept, including anti-VEGF agents. This includes patients receiving a different anti-VEGF agent for the fellow eye

Trial design

163 participants in 1 patient group

Aflibercept
Description:
Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme
Treatment:
Drug: Aflibercept (Eylea, BAY86-5321)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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