Macular Degeneration
Conditions
Keywords
nAMD: neovascular Age-related Macular Degeneration
Brief 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.
Interventions
IVT(Intravitreal) aflibercept treatment in routine clinical practice.
Sponsors
Regeneron Pharmaceuticals
Bayer
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in VA | From baseline to month 12 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients gaining 15 or more letters | At month 6 and 12 | — |
| Mean change in CRT in µm (measured by OCT) | From baseline to months 6 and 12 | OCT:Optical Coherence Tomography |
| 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) | At months 6 and 12 | 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 |
| Presence/absence of PED Height | At months 6 and 12 | 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 |
| Mean change in VA | From baseline to month 6 | — |
| 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 | The first 12 months | Visits only for diagnostic/follow-up purposes, but without injections |
| Mean number of combined visits per study eye | The first 12 months | Visits for monitoring and injection |
| Mean number of OCT assessments per study eye | The first 12 months | — |
| Presence/absence of PED type | At months 6 and 12 | Serous-vascularized or fibrovascular |
Countries
Spain
Outcome results
None listed