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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01840410
Registration number
NCT01840410
Ethics application status
Date submitted
23/04/2013
Date registered
25/04/2013
Date last updated
26/08/2016
Titles & IDs
Public title
Assess the Efficacy/Safety of Intravitreal Ranibizumab in Patients With Vision Loss Due to Choroidal Neovascularization.
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Scientific title
A 12-month, Randomized, Double-masked, Sham-controlled, Multicenter Study to Evaluate the Efficacy and Safety of 0.5mg Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Vascular Endothelial Growth Factor (VEGF) Driven Choroidal Neovascularization.
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Secondary ID [1]
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2012-005417-38
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Secondary ID [2]
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CRFB002G2301
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Choroidal Neovascularization (CNV)
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Cardiovascular
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Other cardiovascular diseases
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Blood
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Haematological diseases
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab
Other interventions - Sham control
Experimental: Ranibizumab - A 0.5 mg ranibizumab intravitreal injection was given to the study eye at baseline, and then as needed based on evidence of disease activity.
Sham comparator: Sham control - Sham injection was given to the study eye at baseline, and then treatment was given based on evidence of disease activity. At Month 1, if treatment was needed, sham was administered. At Month 2, participants could switch to open-label ranibizumab on an as needed basis.
Treatment: Drugs: Ranibizumab
Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
Other interventions: Sham control
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.
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Best-corrected Visual Acuity (BCVA) in Study Eye to Month 2
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Month 2
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Secondary outcome [1]
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Change From Baseline in BCVA in Study Eye up to Month 2
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline, Month 1, Month 2
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Secondary outcome [2]
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Change From Baseline in Central Subfield Thickness (CSFT) in Study Eye
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Assessment method [2]
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CSFT was assessed by optical coherence tomography (OCT). A negative change from baseline indicates improvement.
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Timepoint [2]
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Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Secondary outcome [3]
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Change From Baseline in Central Subfield Volume (CSFV) in Study Eye
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Assessment method [3]
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CSFV was assessed OCT. A negative change from baseline indicates improvement.
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Timepoint [3]
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Baseline, Months 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12
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Secondary outcome [4]
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Number of Participants With Presence of Intra-retinal Fluid in Study Eye Compared to Baseline
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Assessment method [4]
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The presence of intra-retinal fluid was assessed by OCT.
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Timepoint [4]
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Baseline, Month 2, Month 6, Month 12
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Secondary outcome [5]
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Number of Participants With Presence of Subretinal Fluid in Study Eye Compared to Baseline
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Assessment method [5]
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Presence of subretinal fluid in study eye compared to baseline
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Timepoint [5]
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Baseline, Month 2, Month 6, Month 12
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Secondary outcome [6]
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Number of Participants With Presence of Active Chorioretinal Leakage
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Assessment method [6]
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The presence of active chorioretinal leakage was assessed by photography imaging, i.e. fluorescein angiography (FA).
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Timepoint [6]
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Baseline, Month 2, Month 6, Month 12
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Secondary outcome [7]
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Average Change From Baseline in BCVA
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Assessment method [7]
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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.
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Timepoint [7]
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Baseline (BL), Month 1 through Month 6, Month 1 through Month 12
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Secondary outcome [8]
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Number of Participants With = 1, = 5, = 10 and = 15 Letters Gain or Reaching 84 Letters
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Assessment method [8]
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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.
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Timepoint [8]
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Month 2, Month 6, Month 12
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Secondary outcome [9]
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Number of Participants With > 1, > 5, > 10 and > 15 Letters Loss
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Assessment method [9]
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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.
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Timepoint [9]
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Month 2, Month 6, Month 12
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Secondary outcome [10]
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Number of Participants With Requirement for Rescue Treatment at Month 1
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Assessment method [10]
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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.
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Timepoint [10]
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Month 1
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Secondary outcome [11]
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Number of Participants With Ranibizumab Treatments in Study Eye
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Assessment method [11]
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The number of participants administered study treatments, according to treatment frequency, was assessed.
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Timepoint [11]
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Month 12
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Secondary outcome [12]
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Number of Participants With Re-treatments
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Assessment method [12]
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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.
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Timepoint [12]
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Month 12
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Secondary outcome [13]
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Number of Primary Reasons for Decision to Treat by Investigator
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Assessment method [13]
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The total number of primary reasons for decisions to treat was assessed. A single participant could have had multiple primary reasons for treatment.
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Timepoint [13]
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Month 12
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Eligibility
Key inclusion criteria
Key
* Diagnosis of active CNV secondary to any causes with the CNV or its sequelae affecting the fovea;
* BCVA must be between = 24 and = 83 letters in the study eye;
* Visual loss in the study eye should mainly be due to the presence of any eligible types of CNV;
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Women of child-bearing potential;
* Active malignancies;
* History of stroke less than 6 months prior to screening;
* Uncontrolled systemic inflammation or infection;
* Active diabetic retinopathy, active ocular/periocular infectious disease or active severe intra-ocular inflammation;
* CNV- conditions with a high likelihood of spontaneous resolution;
* History of intravitreal treatment with steroids;
* History of laser photocoagulation;
* History of intraocular treatment with any anti-angiogenic drugs.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/11/2015
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Sample size
Target
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Accrual to date
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Final
183
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Recruitment in Australia
Recruitment state(s)
NSW,SA,TAS
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Recruitment hospital [1]
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Novartis Investigative Site - Sydney
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Recruitment hospital [2]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [3]
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Novartis Investigative Site - South Launceston
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Recruitment postcode(s) [1]
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2000 - Sydney
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Recruitment postcode(s) [2]
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5000 - Adelaide
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Recruitment postcode(s) [3]
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7249 - South Launceston
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Recruitment outside Australia
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Canada
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Quebec
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Czech Republic
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Hradec Kralove
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Czech Republic
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Praha 10
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Denmark
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Glostrup
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France
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Paris cedex 10
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France
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State/province [6]
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Paris, Cedex 12
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Duesseldorf
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Germany
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Freiburg i. Br
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Germany
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Leipzig
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Germany
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Muenster
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Germany
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Regensburg
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Germany
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Tübingen
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Greece
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GR
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Greece
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Patras
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Greece
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Thessaloniki
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szeged
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Italy
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BA
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Italy
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CT
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Italy
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MI
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Italy
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RM
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Italy
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UD
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Italy
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VA
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Korea, Republic of
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Korea
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Korea, Republic of
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Busan
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Korea, Republic of
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Seoul
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Latvia
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Riga
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Lithuania
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LTU
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Lithuania
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Vilnius
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Peru
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Lima
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Poland
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Katowice
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Poland
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Wroclaw
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Portugal
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Coimbra
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Portugal
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Porto
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Singapore
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Singapore
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Slovakia
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Banska Bystrica
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Slovakia
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Trencin
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Spain
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Andalucia
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Spain
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Castilla y Leon
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Spain
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Catalunya
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Switzerland
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Bern
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Switzerland
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Binningen
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Switzerland
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Lausanne
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Turkey
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Ankara
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Turkey
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Istanbul
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Turkey
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Kocaeli
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Novartis Pharmaceuticals
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
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).
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Trial website
https://clinicaltrials.gov/study/NCT01840410
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Novartis Pharmaceuticals
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Address
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Novartis Pharmaceuticals
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01840410
Download to PDF