Study 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

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

February 2018 - March 2019

Phase

Phase 4

Could I Receive a placebo

Products

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

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Many locations	Many 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.
Time Frame:
From baseline to month 12

Secondary Outcome

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