Aflibercept Injection Into the Vitreous Body of the Eye: Study to Learn More About Patient Relevant Outcomes, Real World Treatment Patterns and How Well the Treatment Works for Patients Suffering From Abnormal Growth of New Blood Vessels Under the Retina.

Sponsor
Bayer
Study ID
NCT03714308
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

In this clinical study researchers want to gain a deeper understanding of treatment consistence under real world conditions over the course of 24 months of Aflibercept injections into the eye for patients suffering from abnormal growth of new blood vessels under the retina (neovascular age-related macular degeneration). The study aims to identify potential reasons that may allow classification of non-consistence as patient or physician driven. They want to describe treatment effectiveness (how well the treatment works) and associations between treatment effectiveness, non-consistence and patient relevant outcomes, such as vision specific quality of life and treatment satisfaction.

Key Dates

Start date
Jan 28, 2019
Status verified
Jul 2023
Primary completion
Mar 6, 2023
Completion
May 12, 2023

Study Design

Enrollment
554 participants (actual)

Arms

  • Arm: Patients with nAMD_Treatment-naive (anti-VEGF naive)
    Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
  • Arm: Patients with nAMD_Pre-treated with IVT-AFL
    Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months
  • Arm: Patients with nAMD_Pre-treated with any anti-VEGF
    Observational period of therapy with intravitreal aflibercept (IVT-AFL) up to a maximum of 24 months

Primary Outcome Measure

Time to first appearance of non-consistence [ Time Frame: Up to 24 months ]

Related Studies