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 Type
OBSERVATIONAL
Enrollment
116
IVT(Intravitreal) aflibercept treatment in routine clinical practice.
Many locations
Multiple Locations, Spain
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
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
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