This study is designed to provide efficacy and safety data in patients with choroidal neovascularisation (CNV) secondary to myopia using an individualized as-needed (PRN) dosing schedule. Eligible patients who have provided written agreement to take part in the study will receive an intravitreal (into the study eye) injection of ranibizumab 0.5mg. Following eye examinations and tests at monthly clinic visits, the study doctor will repeat the injections on a monthly basis as required for an additional 11 months, in accordance with specified retreatment criteria. Patients will be in the study for approximately 12 months and will visit the hospital clinic 14 times over that period. The main assessments will include visual acuity tests, eye examinations, optical coherence tomography (OCT) to assess retinal thickness, fundus photography and fluorescein angiography (FA), measurement of intraocular pressure, blood pressure and pulse measurements and completion of health-related questionnaires'.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
65
Novartis Investigative Site
Bristol, United Kingdom
Novartis Investigational Site
City of London, United Kingdom
Novartis Investigative Site
City of London, United Kingdom
Novartis Investigative Site
City of London, United Kingdom
Novartis Investigative Site
Frimley, United Kingdom
Novartis Investigative Site
Leeds, United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, United Kingdom
Novartis Investigative Site
Nottingham, United Kingdom
Novartis Investigative Site
Southampton, United Kingdom
Novartis Investigative Site
Torquay, United Kingdom
...and 2 more locations
The difference from baseline in mean Best Corrected Visual Acuity (BCVA)
Time frame: 12 months
Mean change in BCVA from baseline
Time frame: 6 months
Mean change in Central retinal Thickness (CRT) from baseline
Time frame: 6 and 12 months
Percentage of patients gaining ≥ 15 letters
Time frame: 12 months
Change in lesion size and morphology from baseline
Time frame: 6 and 12 months
Time to the first retreatment and the total number of treatments
Time frame: 12 Months
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