Trial Condition(s):

Macular degeneration

Evaluate the effectiveness of intravitreal (IVT) aflibercept injection in clinical practice in naïve patients with neovascular age-related macular degeneration (nAMD) (REALE)

Bayer Identifier:

18798

ClinicalTrials.gov Identifier:

NCT03411941

EudraCT Number:

Not Available

Study Completed

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.

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.

Trial Summary

Enrollment Goal
116
Trial Dates
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Phase
4
Could I receive a placebo?
No
Products
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Many locations

Many locations, Spain

Status
Completed
 

Trial Design