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

N/ATerminatedNCT02005133

Novartis Pharmaceuticals188 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

188

Conditions

Wet Age-related Macular Degeneration

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (17)

Novartis Investigative Site

Taunton, Somerset, United Kingdom

Novartis Investigative Site

Frimley, Surrey, United Kingdom

Outcomes

Primary Outcomes

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.

Time frame: Up to 1 year

Secondary Outcomes

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.

Time frame: Up to 1 year

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.

Time frame: Up to 2 years

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.

Time frame: Up to 2 years

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

Time frame: Up to 2 years

Data from ClinicalTrials.gov

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