This is an observational study to will evaluate and compare two Ranibizumab treatment regimens (Standard of care) in patients with neovascular (wet) age-related macular degeneration (wAMD) aiming to achieve and to maintain a maximum visual function benefit. The results will be used to generate further recommendations on the timing of treatment administration for patients with neovascular (wet) age-related macular degeneration (wAMD). In this context, the study will use the anatomical imaging (for example, optical coherence tomography \[OCT\]) to evaluate wAMD disease activity impacted by the recurrence of disease instability and for decision making in the treatment decision algorithm.
Study Type
OBSERVATIONAL
Enrollment
505
All eligible patients will initially be treated in a fixed loading phase, consisting of one intravitreal injection of Ranibizumab 0.5 mg per month for 3 consecutive months (Day 1, Month 1, and Month 2). After the loading phase, patients will be treated according to the treatment arm to which they have been assigned, either a continued once monthly dosing regimen, or an extended schedule of Ranibizumab intravitreal injections as described below. The planned duration of total treatment is 24 months.
Novartis Investigative Site
Calgary, Alberta, Canada
Novartis Investigative Site
Edmonton, Alberta, Canada
Novartis Investigative Site
Moncton, New Brunswick, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada
Novartis Investigative Site
St. John's, Newfoundland and Labrador, Canada
Novartis Investigative Site
Brampton, Ontario, Canada
Novartis Investigative Site
Hamilton, Ontario, Canada
Novartis Investigative Site
London, Ontario, Canada
Novartis Investigative Site
Missisauga, Ontario, Canada
Novartis Investigative Site
Ottawa, Ontario, Canada
...and 14 more locations
Mean Change in Visual Acuity
Visual Acuity (VA) will be assessed using best correction determined from protocol refraction during screening and every 3 months throughout the study; in the monthly regimen and during screening and at every visit thereafter throughout the study in the treat and extend regimen. VA measurements (number of letters correctly identified) will be performed with the patient in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like VA testing charts at an initial testing distance of 4 meters. This outcome measure will describe the difference in the VA mean changes between the two regimens from Baseline to Month 12.
Time frame: Baseline to Month 12
Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.
Time frame: Baseline to Month 12
Proportion of patients with a gain of equal or more than 5, 10, and 15 letters between the 2 treatment arms.
Time frame: Baseline to Month 24
Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms from baseline to Month 12 and from baseline to Month 24.
Time frame: baseline to Month 12
Proportion of patients with a loss of less than 5, 10, and 15 letters between the 2 treatment arms.
Time frame: baseline to Month 24
Mean change in BCVA ETDRS between the 2 treatment arms at Month 12 compared to Month 3.
Time frame: Month 12 and Month 3
Mean change in BCVA ETDRS between the 2 treatment arms.
Time frame: Baseline to Month 24
Number of injections performed in each treatment arms.
Time frame: Baseline to Month 24
Number of injections performed in each treatment arms.
Time frame: Month 12 to Month 24
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