Prospective Observational Study to Assess Effectiveness of Intravitreal Aflibercept in Patients With Wet Macular Degeneration in Greece

Sponsor
Bayer
Study ID
NCT02821247
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
50 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Aflibercept (Eylea, BAY86-5321) — DRUG
    Intravitreal injection; should comply with the recommendations written in the local Summary of Product Characteristics (SPC) of the product

Study Details

This is a prospective, observational, multi-center, study. The study will be conducted in approximately 12 ophthalmological clinics and practices throughout Greece. It is planned to collect data on treatment of wet Age related Macular Degeneration (wAMD) from about 120 patients for which the decision to treat with intravitreal aflibercept injections is made at the discretion of the attending physician, according to his/her medical practice. Visits will be performed at baseline, aflibercept first injection (if different from enrollment) and at 12 and 24 months. The 12 and 24 month comprise the data collection visits during which any data generated in the period preceding these visits will be recorded. All required information for the purposes of this study will be collected using electronic Case Record Form (eCRF). The web-based electronic data capture (EDC) application will be specifically designed for the needs of the study and will adhere to all applicable data protection regulations and requirements with regard to electronic records. The study observation period for each patient enrolled in this study is the time from the beginning of treatment with intravitreal aflibercept injection up to two years or until discontinuation of intravitreal aflibercept injection-treatment due to any reason including withdrawal of consent or patient loss from follow-up.

Key Dates

Start date
Jul 1, 2016
Status verified
Nov 2020
Primary completion
Jul 10, 2019
Completion
Dec 13, 2019

Study Design

Enrollment
119 participants (actual)

Arms

  • Arm: Aflibercept
    Adult wet Age Related Macular degeneration (AMD) treatment naïve partcipants were treated with intravitreal aflibercept injection

Primary Outcome Measure

Mean change of visual acuity from baseline to 12 months [ Time Frame: At baseline and 12 months ]

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