Clinical trial NCT03411941: Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Degeneration
Keywords: nAMD: neovascular Age-related Macular Degeneration
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2018-01-26
Enrollment: 116
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will include data from adult patients newly diagnosed with nAMD who initiated and maintained anti-VEGF treatment with IVT aflibercept injection in 8 Spanish centers which treat AMD patients routinely.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change in VA
timeFrame: From baseline to month 12
Secondary outcomes:
measure: Mean change in VA
timeFrame: From baseline to month 6
measure: Proportion of patients gaining 15 or more letters
timeFrame: At month 6 and 12
measure: Mean change in CRT in µm (measured by OCT)
timeFrame: From baseline to months 6 and 12
measure: Presence/absence of SRF (subretinal fluid) by OCT (yes/no)
timeFrame: At months 6 and 12
measure: Presence/absence of IRF (intraretinal fluid) by OCT (yes/no)
timeFrame: At months 6 and 12
measure: Presence/absence of PED (pigment epithelium detachment) (measured by OCT)
timeFrame: At months 6 and 12
measure: Presence/absence of PED Height
timeFrame: At months 6 and 12
measure: Presence/absence of PED type
timeFrame: At months 6 and 12
measure: Correlation of the mean gain in VA with the total number of injections administered
timeFrame: 12 months
measure: Mean number of IVT aflibercept injections per study eye
timeFrame: The first 12 months
measure: Mean number of monitoring visits per study eye
timeFrame: The first 12 months
measure: Mean number of combined visits per study eye
timeFrame: The first 12 months
measure: Mean number of OCT assessments per study eye
timeFrame: The first 12 months
Other outcomes:
Locations:
city: Multiple Locations
country: Spain
facility: Many locations
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: