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

Overview

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 Title of Study: “An Observational Study to Assess the Use of Intravitreal Aflibercept Injections in a Routine “Treat and Extend” Regimen in Treatment-naïve Patients Diagnosed With Wet Age-related Macular Degeneration”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Other
  • Study Primary Completion Date: November 9, 2018

Detailed 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.

Interventions

  • Drug: Aflibercept (Eylea, BAY86-5321)
    • 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

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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
    • mean change in ETDRS letters

Secondary Measures

  • Mean change from baseline in best-corrected visual acuity (in Early Treatment Diabetic Retinopathy Study (ETDRS) letters)
    • Time Frame: Baseline and at 24 months
    • mean change in ETDRS letters
  • Mean change in best-corrected visual acuity in relation to the number of injections administered
    • Time Frame: Baseline and at 12 months; Baseline and at 24 months
    • Numbers of injections will be predefined as categories and analyzed in relation to the BCVA changes
  • Mean interval between injections
    • Time Frame: At 12 and 24 months
    • mean interval displayed in weeks or days
  • Reasons for the interval length
    • Time Frame: At 12 and 24 months
    • morphology and / or BCVA /other
  • Frequency of disease reactivation
    • Time Frame: Baseline and at 12 months; Baseline and at 24 months
    • Disease activity such as hemorrhage, PED, subretinal fluid, cystoid intraretinal fluid, RPE rip assessed at the investigator’s discretion as: none / new or increasing / decreasing / stable
  • Proportion of eyes gaining or losing ≥ 15 Early Treatment Diabetic Retinopathy Study letters compared to baseline
    • Time Frame: Baseline and at 12 months; Baseline and at 24 months
    • Proportion evaluated as percentage (%) of eyes
  • Mean changes from baseline in central retinal thickness (CRT)
    • Time Frame: Baseline and at 3 months; Baseline and at 12 months; Baseline and 24 months
    • micro meter (µm)
  • Changes from baseline in retinal fluid
    • Time Frame: Baseline and at 12 months; Baseline and at 24 months
    • intraretinal or subretinal fluid or pigment epithelial detachment (PED)
  • Reasons for termination of therapy (including subsequent therapy at time of discontinuation)
    • Time Frame: At 12 and 24 months
    • Categorized into typical reasons for discontinuation such as e.g. death, lost to Follow-up, withdrawal of informed consent, change of treatment regimen, discontinuation of IVT-AFL treatment, interfering surgery or treatment, adverse event, other
  • Severity of disease reactivation
    • Time Frame: Baseline and at 12 months; Baseline and at 24 months
    • Severity of disease reactivation assessed at the investigator’s discretion as: no new disease activity / mild / severe

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 55 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Collaborator
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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