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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

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ClinicalTrials.gov Identifier: NCT02005133
Recruitment Status : Terminated
First Posted : December 9, 2013
Last Update Posted : February 28, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease
Wet Age-related Macular Degeneration

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Study Type : Observational
Actual Enrollment : 188 participants
Observational Model: Other
Time Perspective: Prospective
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 Start Date : November 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Group/Cohort
VEGF inhibitor naïve
VEGF inhibitor prior treated



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005133


Locations
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United Kingdom
Novartis Investigative Site
Taunton, Somerset, United Kingdom, TA1 5DA
Novartis Investigative Site
Frimley, Surrey, United Kingdom, GU16 7UJ
Novartis Investigative Site
Bradford, West Yorkshire, United Kingdom, BD9 6RJ
Novartis Investigative Site
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Novartis Investigative Site
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, EC1V 2PD
Novartis Investigative Site
London, United Kingdom, SE5 9RS
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
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharnmaceuticals Novartis

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02005133     History of Changes
Other Study ID Numbers: CRFB002AGB16
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: February 28, 2017
Last Verified: February 2017

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Wet age-related macular degeneration

Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases