Evaluate the Effectiveness of Intravitreal (IVT) Afliberc... | NCT03411941

Status Module

Record Verification Date

Dec 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 28, 2018Actual

Primary Completion Date

Mar 1, 2019Actual

Completion Date

Mar 1, 2019Actual

First Submitted Date

Jan 21, 2018

First Submission Date that Met QC Criteria

Jan 25, 2018

First Posted Date

Jan 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2019

Last Update Posted Date

Dec 5, 2019Actual

Name	Class
Regeneron Pharmaceuticals	INDUSTRY

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

116Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)	Drug	IVT(Intravitreal) aflibercept treatment in routine clinical practice.	Treatment-naïve nAMD patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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)

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases