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Completed

NCT Number: NCT03411941

Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)

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.

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Key information

Conditions

Macular Degeneration Eye Diseases Retinal Degeneration Retinal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

Drug

IVT(Intravitreal) aflibercept treatment in routine clinical practice.

Primary outcomes

  1. Mean change in VA

    Time frame: From baseline to month 12

    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.

Secondary outcomes

  1. Mean change in VA

    Time frame: From baseline to month 6

  2. Proportion of patients gaining 15 or more letters

    Time frame: At month 6 and 12

  3. Mean change in CRT in µm (measured by OCT)

    Time frame: From baseline to months 6 and 12

    OCT:Optical Coherence Tomography

  4. Presence/absence of SRF (subretinal fluid) by OCT (yes/no)

    Time frame: At months 6 and 12

  5. Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)

    Time frame: At months 6 and 12

  6. Presence/absence of PED (pigment epithelium detachment) (measured by OCT)

    Time frame: At months 6 and 12

    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

  7. Presence/absence of PED Height

    Time frame: At months 6 and 12

    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

  8. Presence/absence of PED type

    Time frame: At months 6 and 12

    Serous-vascularized or fibrovascular

  9. Correlation of the mean gain in VA with the total number of injections administered

    Time frame: 12 months

  10. Mean number of IVT aflibercept injections per study eye

    Time frame: The first 12 months

  11. Mean number of monitoring visits per study eye

    Time frame: The first 12 months

    Visits only for diagnostic/follow-up purposes, but without injections

  12. Mean number of combined visits per study eye

    Time frame: The first 12 months

    Visits for monitoring and injection

  13. Mean number of OCT assessments per study eye

    Time frame: The first 12 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Collaborators

  • Regeneron Pharmaceuticals

Registry information

Official study title

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)

Acronym: REALE

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 26, 2018
Registry last updated
Dec 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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