check_circleStudy Completed

Macular Degeneration

Bayer Identifier:

18798

ClinicalTrials.gov Identifier:

NCT03411941

EudraCT Number:

Not Available

EU CT Number:

Not Available
Evaluate the effectiveness of intravitreal (IVT) aflibercept injection in clinical practice in naïve patients with neovascular age-related macular degeneration (nAMD)

Trial purpose

There is a need to investigate the effectiveness of IVT aflibercept injection in routine clinical practice.
The aim of this study is to collect 12-month real-world clinical data from treatment-naïve nAMD patients who started first-line treatment with IVT aflibercept injection, according to the SmPC (Summary of Product Characteristics) and the SERV (Spanish Society of Retina and Vitreous) guidelines. The effectiveness of IVT aflibercept will be assessed by the changes in VA (Visual Acuity) and CRT (Central Retinal Thickness) during treatment.

Key Participants Requirements

Sex

All

Age

50 - N/A
  • - Adult patient aged 50 years or more at aflibercept treatment initiation.
    - Treatment-naïve patients with nAMD
    - Patients who initated treatment with IVT aflibercept injection between 1st April 2014 to 31st May 2016
    - Patients that have been decided to be treated with IVT aflibercept with a minimum treatment follow-up with IVT aflibercept injection of at least 12-months, in accordance with the approved SmPC.
    - Patients who have been provided with appropriate information about the study objectives and procedures and who have given their written informed consent.


  • - Patients who have previously been treated with anti-VEGF intravitreal injections, systemic anti-VEGF or pro-VEGF treatments, as well as other intravitreal steroids or steroid implants for the study eye.
    - Patients that switched to another treatment alternative different from IVT aflibercept injection during observation period of 12 months
    - Patients with another retinal disease: diabetic retinopathy, diabetic macular edema (DME), myopic choroidal neovascularization, retinal vein occlusion (RVO), central serous chorioretinopathy (CSC), angioid streaks.
    - Patients with scarring, fibrosis, or atrophy involving the center of the fovea in the study eye at treatment initiation
    - Patients with advanced cataract or advanced glaucoma
    - Patients with presence of retinal pigment epithelial tears or rips involving the macula in the study eye prior to treatment initiation.
    - Patients who do not meet the local Guideline criteria for aflibercept treatment. Contraindications listed in the SmPC must be taken into account.

Trial summary

Enrollment Goal
116
Trial Dates
February 2018 - March 2019
Phase
Phase 4
Could I Receive a placebo
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many locationsMany locations, Spain

Primary Outcome

  • Mean change in VA
    The mean change in VA from baseline (i.e. just prior to the start of treatment) to 12 months in treatment-naïve patients with nAMD in routine clinical practice in Spain.
    date_rangeTime Frame:
    From baseline to month 12

Secondary Outcome

  • Mean change in VA
    date_rangeTime Frame:
    From baseline to month 6
  • Proportion of patients gaining 15 or more letters
    date_rangeTime Frame:
    At month 6 and 12
  • Mean change in CRT in µm (measured by OCT)
    OCT:Optical Coherence Tomography
    date_rangeTime Frame:
    From baseline to months 6 and 12
  • Presence/absence of SRF (subretinal fluid) by OCT (yes/no)
    date_rangeTime Frame:
    At months 6 and 12
  • Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)
    date_rangeTime Frame:
    At months 6 and 12
  • Presence/absence of PED (pigment epithelium detachment) (measured by OCT)
    Absence of PED: when the maximum distance between the outer border of the RPE and the inner border of the Bruch membrane is <30 μm
    date_rangeTime Frame:
    At months 6 and 12
  • Presence/absence of PED Height
    Subfoveal and 500µm nasal and temporal; PED height defined as the distance between the outer border of the retinal pigment epithelium (RPE) and the inner border of the Bruch membrane
    date_rangeTime Frame:
    At months 6 and 12
  • Presence/absence of PED type
    Serous-vascularized or fibrovascular
    date_rangeTime Frame:
    At months 6 and 12
  • Correlation of the mean gain in VA with the total number of injections administered
    date_rangeTime Frame:
    12 months
  • Mean number of IVT aflibercept injections per study eye
    date_rangeTime Frame:
    The first 12 months
  • Mean number of monitoring visits per study eye
    Visits only for diagnostic/follow-up purposes, but without injections
    date_rangeTime Frame:
    The first 12 months
  • Mean number of combined visits per study eye
    Visits for monitoring and injection
    date_rangeTime Frame:
    The first 12 months
  • Mean number of OCT assessments per study eye
    date_rangeTime Frame:
    The first 12 months

Trial design

Observational, retrospective study to evaluate the effectiveness of intravitreal (IVT) aflibercept injection in clinical practice in naïve patients with neovascular age-related macular degeneration (nAMD)
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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