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
1 other identifier
observational
188
1 country
17
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2013
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 3, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedFebruary 28, 2017
February 1, 2017
1.9 years
December 3, 2013
February 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Frequency of aflibercept administration
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 Outcomes (4)
Frequency of clinic visits
Up to 1 year
Aflibercept Administration
Up to 2 years
Changes in visual acuity from baseline
Up to 2 years
Change in central retinal thickness from baseline
Up to 2 years
Study Arms (2)
VEGF inhibitor naïve
VEGF inhibitor prior treated
Eligibility Criteria
Male and female subjects diagnosed with visual impairment due to wet AMD who are undergoing routine assessment in UK opthalmology clinics.
You may qualify if:
- \- 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
You may not qualify if:
- \- Patients must not have had any prior use of either bevacizumab or aflibercept
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Novartis Investigative Site
Taunton, Somerset, TA1 5DA, United Kingdom
Novartis Investigative Site
Frimley, Surrey, GU16 7UJ, United Kingdom
Novartis Investigative Site
London, United Kingdom, EC1V 2PD, United Kingdom
Novartis Investigative Site
Bradford, West Yorkshire, BD9 6RJ, United Kingdom
Novartis Investigative Site
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Novartis Investigative Site
Bolton, BL4 0JR, United Kingdom
Novartis Investigative Site
Bristol, BS1 2LX, United Kingdom
Novartis Investigative Site
Guildford, Surrey, GU2 5XX, United Kingdom
Novartis Investigative Site
Kent, CT1 3NG, United Kingdom
Novartis Investigative Site
Liverpool, L7 8XP, United Kingdom
Novartis Investigative Site
London, SE5 9RS, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, NE1 4LP, United Kingdom
Novartis Investigative Site
Southampton, SO16 6YD, United Kingdom
Novartis Investigative Site
Southend, SS0 0RY, United Kingdom
Novartis Investigative Site
Sunderland, SR2 9HP, United Kingdom
Novartis Investigative Site
Uxbridge, UB8 3NN, United Kingdom
Novartis Investigative Site
York, YO31 8HE, United Kingdom
Study Officials
- STUDY DIRECTOR
Novartis Pharnmaceuticals
Novartis
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2013
First Posted
December 9, 2013
Study Start
November 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
February 28, 2017
Record last verified: 2017-02