Evaluate the Effectiveness of Intravitreal (IVT) Aflibercept Injection in Clinical Practice in naïve Patients With Neovascular Age-related Macular Degeneration (nAMD)

NCT03411941 | Completed

• 1 other identifier: 18798
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Degeneration

Keywords

nAMD: neovascular Age-related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to month 12

Secondary Outcomes (13)

• Mean change in VA

  From baseline to month 6

• 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

• 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

Study Arms (1)

Treatment-naïve nAMD patients

Patient data for whom treatment with IVT aflibercept injection was initiated as first-line treatment according to the SmPC and the SERV Guideline, in treatment-naive patients with newly diagnosed of nAMD in routine clinical practice.

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

Interventions

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

IVT(Intravitreal) aflibercept treatment in routine clinical practice.

Treatment-naïve nAMD patients

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bayer: lead
• Regeneron Pharmaceuticals: collaborator

Study Sites (1)

Many locations

Multiple Locations, Spain

Location

Related Links

• Click here to find results for studies related to Bayer products.

MeSH Terms

Conditions

Macular Degeneration

Interventions

aflibercept

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2018
• First Posted: January 26, 2018
• Study Start: February 28, 2018
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: December 5, 2019

Record last verified: 2019-12

Locations

ES (1)