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

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)

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.

Study Overview

• Status: Completed
• Conditions: Macular Degeneration
• Intervention / Treatment: Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)

• Study Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

Study Locations

• Spain
  • Multiple Locations, Spain
    • Many Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will include data from adult patients newly diagnosed with nAMD who initiated and maintained anti-VEGF treatment with IVT aflibercept injection in 8 Spanish centers which treat AMD patients routinely.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment-naïve nAMD patients; Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice.	Drug: Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321); IVT(Intravitreal) aflibercept treatment in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline to month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in VA		From baseline to month 6
Proportion of patients gaining 15 or more letters		At month 6 and 12
Mean change in CRT in µm (measured by OCT)	OCT:Optical Coherence Tomography	From baseline to months 6 and 12
Presence/absence of SRF (subretinal fluid) by OCT (yes/no)		At months 6 and 12
Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)		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	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	At months 6 and 12
Presence/absence of PED type	Serous-vascularized or fibrovascular	At months 6 and 12
Correlation of the mean gain in VA with the total number of injections administered		12 months
Mean number of IVT aflibercept injections per study eye		The first 12 months
Mean number of monitoring visits per study eye	Visits only for diagnostic/follow-up purposes, but without injections	The first 12 months
Mean number of combined visits per study eye	Visits for monitoring and injection	The first 12 months
Mean number of OCT assessments per study eye		The first 12 months

Collaborators and Investigators

• Sponsor: Bayer
• Collaborators: Regeneron Pharmaceuticals

Publications and helpful links

Helpful Links

• Click here to find results for studies related to Bayer products.

Study record dates

Study Major Dates

• Study Start (Actual): February 28, 2018
• Primary Completion (Actual): March 1, 2019
• Study Completion (Actual): March 1, 2019

Study Registration Dates

• First Submitted: January 21, 2018
• First Submitted That Met QC Criteria: January 25, 2018
• First Posted (Actual): January 26, 2018

Study Record Updates

• Last Update Posted (Actual): December 5, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: nAMD: neovascular Age-related Macular Degeneration
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Wet Macular Degeneration; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept
• Other Study ID Numbers: 18798 (HSREB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No