Clinical trial NCT02005133: 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
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Wet Age-related Macular Degeneration
Keywords: Wet age-related macular degeneration
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 188
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of aflibercept administration
timeFrame: Up to 1 year
Secondary outcomes:
measure: Frequency of clinic visits
timeFrame: Up to 1 year
measure: Aflibercept Administration
timeFrame: Up to 2 years
measure: Changes in visual acuity from baseline
timeFrame: Up to 2 years
measure: Change in central retinal thickness from baseline
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Taunton
country: United Kingdom
facility: Novartis Investigative Site
state: Somerset
city: Frimley
country: United Kingdom
facility: Novartis Investigative Site
state: Surrey
city: Bradford
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Leeds
country: United Kingdom
facility: Novartis Investigative Site
state: West Yorkshire
city: Bolton
country: United Kingdom
facility: Novartis Investigative Site
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
city: Guildford, Surrey
country: United Kingdom
facility: Novartis Investigative Site
city: Kent
country: United Kingdom
facility: Novartis Investigative Site
city: Liverpool
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Newcastle upon Tyne
country: United Kingdom
facility: Novartis Investigative Site
city: Southampton
country: United Kingdom
facility: Novartis Investigative Site
city: Southend
country: United Kingdom
facility: Novartis Investigative Site
city: Sunderland
country: United Kingdom
facility: Novartis Investigative Site
city: Uxbridge
country: United Kingdom
facility: Novartis Investigative Site
city: York
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis
name: Novartis Pharnmaceuticals
role: STUDY_DIRECTOR
References: