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

Macular Degeneration Clinical Trial

— REALE  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03411941
• Other study ID #: 18798
• Status: Completed
• Start date: February 28, 2018
• Est. completion date: March 1, 2019

Study information

• Verified date: December 2019
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 116
• Est. completion date: March 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
IVT(Intravitreal) aflibercept treatment in routine clinical practice.

Locations

Country	Name	City	State
Spain	Many locations	Multiple Locations

Sponsors (2)

Lead Sponsor	Collaborator
Bayer	Regeneron Pharmaceuticals

Country where clinical trial is conducted

Spain, 

Outcome

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

External Links

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