This study was conducted to evaluate the efficacy and safety of 0.5 mg ranibizumab in adult and adolescent patients with visual impairment due to choridal neovascularization (CNV).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
183
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using mixed model repeated measures (MMRM) which contained scheduled visit, the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate and treatment group by visit and visit by centered baseline BCVA interactions. A positive change from baseline indicated improvement.
Time frame: Baseline, Month 2
Change From Baseline in BCVA in Study Eye up to Month 2
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. The data were analyzed using analysis of covariance (ANCOVA) model which contained the type of underlying pathophysiologic mechanism (angloid streaks versus others) and treatment group as fixed effect factors, centered baseline BCVA as a continuous covariate. A positive change from baseline indicated improvement.
Time frame: Baseline, Month 1, Month 2
Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
CSFV was assessed OCT. A negative change from baseline indicates improvement.
Time frame: Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
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Novartis Investigative Site
Sydney, New South Wales, Australia
Novartis Investigative Site
Adelaide, South Australia, Australia
Novartis Investigative Site
South Launceston, Tasmania, Australia
Novartis Investigative Site
Montreal, Quebec, Canada
Novartis Investigative Site
Hradec Králové, Czechia
Novartis Investigative Site
Prague, Czechia
Novartis Investigative Site
Glostrup Municipality, Denmark
Novartis Investigative Site
Paris, France, France
Novartis Investigative Site
Paris, France
Novartis Investigative Site
Leipzig, Germany, Germany
...and 49 more locations
The presence of intra-retinal fluid was assessed by OCT.
Time frame: Baseline, Month 2, Month 6, Month 12
Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
Presence of subretinal fluid in study eye compared to baseline
Time frame: Baseline, Month 2, Month 6, Month 12
Number of Participants With Presence of Active Chorioretinal Leakage
The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
Time frame: Baseline, Month 2, Month 6, Month 12
Average Change From Baseline in BCVA
BCVA was assessed in a sitting position using Early Treatment Diabetic Retinopathy Study (ETDRS)-like visual acuity (VA) testing charts at an initial testing distance of 4 meters. BCVA was assessed at each month from Month 1 through Month 6 or at each month from Month 1 through month 12, and the data were averaged. The outcome measure is reporting the change between baseline and average BCVA from Month 1 through Month 6 or from Month 1 through Month 12 (average BCVA - baseline BCVA). A positive change from baseline indicated improvement.
Time frame: Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
Number of Participants With ≥ 1, ≥ 5, ≥ 10 and ≥ 15 Letters Gain or Reaching 84 Letters
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time frame: Month 2, Month 6, Month 12
Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
VA measurements (number of letters correctly identified) were performed with the patient in a sitting position using ETDRS-like visual acuity testing charts at a testing distance of 4 meters.
Time frame: Month 2, Month 6, Month 12
Number of Participants With Requirement for Rescue Treatment at Month 1
Rescue treatment with laser photocoagulation or periocular treatment could be administered at Month 1 only if the participant had a visual acuity loss of \> 5 letters due to disease activity from baseline to Month 1.
Time frame: Month 1
Number of Participants With Ranibizumab Treatments in Study Eye
The number of participants administered study treatments, according to treatment frequency, was assessed.
Time frame: Month 12
Number of Participants With Re-treatments
The number of participants, administered re-treatments according to treatment frequency, was assessed. Re-treatment was defined as an administration of study medication following at least one non-missed visit where treatment was not administered in the study eye. Up to month 12, the maximum number of retreatments was 5.
Time frame: Month 12
Number of Primary Reasons for Decision to Treat by Investigator
The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
Time frame: Month 12