Wet Age-related Macular Degeneration Clinical Trial
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
| Verified date | February 2017 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 188 |
| Est. completion date | October 2015 |
| Est. primary completion date | October 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Novartis Investigative Site | Bolton | |
| United Kingdom | Novartis Investigative Site | Bradford | West Yorkshire |
| United Kingdom | Novartis Investigative Site | Bristol | |
| United Kingdom | Novartis Investigative Site | Frimley | Surrey |
| United Kingdom | Novartis Investigative Site | Guildford, Surrey | |
| United Kingdom | Novartis Investigative Site | Kent | |
| United Kingdom | Novartis Investigative Site | Leeds | West Yorkshire |
| United Kingdom | Novartis Investigative Site | Liverpool | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | London | |
| United Kingdom | Novartis Investigative Site | Newcastle upon Tyne | |
| United Kingdom | Novartis Investigative Site | Southampton | |
| United Kingdom | Novartis Investigative Site | Southend | |
| United Kingdom | Novartis Investigative Site | Sunderland | |
| United Kingdom | Novartis Investigative Site | Taunton | Somerset |
| United Kingdom | Novartis Investigative Site | Uxbridge | |
| United Kingdom | Novartis Investigative Site | York |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Frequency of clinic visits | 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 | |
| Secondary | Aflibercept Administration | 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 | |
| Secondary | Changes in visual acuity from baseline | 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 | |
| Secondary | Change in central retinal thickness from baseline | 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 |
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