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

Sponsor
Bayer
Study ID
NCT03382587
Status
Completed

Conditions

  • Wet Age-related Macular Degeneration

Eligibility Criteria

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

Interventions

  • Aflibercept (Eylea, BAY86-5321) — DRUG
    Intravitreal aflibercept injections used in a routine "treat and extend" regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day

Study Details

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.

Key Dates

Start date
Dec 5, 2017
Status verified
Jun 2023
Primary completion
Nov 9, 2018
Completion
Nov 27, 2018

Study Design

Enrollment
163 participants (actual)

Arms

  • Arm: Aflibercept
    Treatment-naive wet age-related macular degeneration patients under routine intravitreal aflibercept treatment in a treat-and-extend scheme

Primary Outcome Measure

Mean change from baseline in best-corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters (ETDRS letters) [ Time Frame: Baseline and at 12 months ]

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