A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics

February 27, 2017 updated by: Novartis Pharmaceuticals
To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior treated wet AMD patients managed in 'real wold' clinic settings.

Study Overview

Status

Terminated

Conditions

Study Type

Observational

Enrollment (Actual)

188

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bolton, United Kingdom, BL4 0JR
        • Novartis Investigative Site
      • Bristol, United Kingdom, BS1 2LX
        • Novartis Investigative Site
      • Guildford, Surrey, United Kingdom, GU2 5XX
        • Novartis Investigative Site
      • Kent, United Kingdom, CT1 3NG
        • Novartis Investigative Site
      • Liverpool, United Kingdom, L7 8XP
        • Novartis Investigative Site
      • London, United Kingdom, SE5 9RS
        • Novartis Investigative Site
      • London, United Kingdom, EC1V 2PD
        • Novartis Investigative Site
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Novartis Investigative Site
      • Southampton, United Kingdom, SO16 6YD
        • Novartis Investigative Site
      • Southend, United Kingdom, SS0 0RY
        • Novartis Investigative Site
      • Sunderland, United Kingdom, SR2 9HP
        • Novartis Investigative Site
      • Uxbridge, United Kingdom, UB8 3NN
        • Novartis Investigative Site
      • York, United Kingdom, YO31 8HE
        • Novartis Investigative Site
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Novartis Investigative Site
    • Surrey
      • Frimley, Surrey, United Kingdom, GU16 7UJ
        • Novartis Investigative Site
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Novartis Investigative Site
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Male and female subjects diagnosed with visual impairment due to wet AMD who are undergoing routine assessment in UK opthalmology clinics.

Description

Inclusion Criteria:

- Age greater or equal to 50 years Active choroidal neovascularisation secondary to AMD in one or both eyes which in the opinion of the investigator will benefit from treatment with aflibercept Subject willing and able to provide informed consent

Exclusion Criteria:

- Patients must not have had any prior use of either bevacizumab or aflibercept

Other protocol-defined inclusion/exclusion criteria may apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
VEGF inhibitor naïve
VEGF inhibitor prior treated

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of aflibercept administration
Time Frame: Up to 1 year
To assess the frequency of clinic visits over a 1 year period in VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings.
Up to 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of clinic visits
Time Frame: Up to 1 year
To assess how frequently aflibercept is administered over a 2 year period to VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings and to determine how frequently these subjects are seen in the clinic.
Up to 1 year
Aflibercept Administration
Time Frame: Up to 2 years
To assess how frequently aflibercept is administered over 1 year and 2 year periods to prior treated VEGF inhibitor treated wet AMD subjects managed in 'real world' clinic settings and to determine how frequently these subjects are seen in the clinic.
Up to 2 years
Changes in visual acuity from baseline
Time Frame: Up to 2 years
To assess how visual acuity changes over 1 year and 2 year periods in both VEGF inhibitor naive and prior treated wet AMD subjects that receive aflibercept.
Up to 2 years
Change in central retinal thickness from baseline
Time Frame: Up to 2 years
To assess how central retinal thickness (CRT) changes as determined by optical coherence tomography OCT) over a 1 year and 2 year period in both VEGF inhibitor naive and prior treated wet AMD subjects that receive aflibercept
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharnmaceuticals, Novartis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

December 3, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

February 28, 2017

Last Update Submitted That Met QC Criteria

February 27, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002AGB16

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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