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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01535261
Registration number
NCT01535261
Ethics application status
Date submitted
14/02/2012
Date registered
17/02/2012
Date last updated
27/10/2016
Titles & IDs
Public title
Ranibizumab Intravitreal Injections in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal Vein Occlusion
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Scientific title
A 24-month, Phase IIIb, Open-label, Single Arm, Multicenter Study Assessing the Efficacy and Safety of an Individualized, Stabilization-criteria-driven PRN Dosing Regimen With 0.5-mg Ranibizumab Intravitreal Injections Applied as Monotherapy in Patients With Visual Impairment Due to Macular Edema Secondary to Central Retinal
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Secondary ID [1]
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2011-002350-31
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Secondary ID [2]
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CRFB002E2401
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Universal Trial Number (UTN)
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Trial acronym
CRYSTAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Macular Edema
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Central Retinal Vein Occlusion
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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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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab 0.5 mg/0.05 ml
Experimental: Ranibizumab arm - Intravitreal injection with standard dose of 0.5 mg/0.05mL PRN
Treatment: Drugs: Ranibizumab 0.5 mg/0.05 ml
Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.
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Intervention code [1]
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Treatment: Drugs
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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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Mean Change in Best Corrected Visual Acuity (BCVA) at Month 12 Compared to Baseline
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Assessment method [1]
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Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
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Timepoint [1]
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Baseline to month 12
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Secondary outcome [1]
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Mean Change in Best Corrected Visual Acuity (BCVA) at Month 24 Compared to Baseline
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Assessment method [1]
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Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. A positive average change from baseline of BCVA indicates improvement
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Timepoint [1]
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Baseline to Month 24
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Secondary outcome [2]
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Mean Average Change in Best Corrected Visual Acuity (BCVA From Baseline Month 12 and Month 24
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Assessment method [2]
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Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Mean Average Change: for each patient, first average change is calculated as the average of the changes from baseline to Month 1 over Month 12 (or Month 24). Then, mean average change is calculated as the average of average changes across all patients.
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Timepoint [2]
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Baseline and Month 1 to 12 or Month 24
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Secondary outcome [3]
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Mean Average Change in BCVA From First Treatment Interruption (Due to BCVA Stabilization) to Month 12 and Month 24
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Assessment method [3]
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Best-Corrected Visual Acuity (BCVA) letters was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart while participants were in a sitting position at a testing distance of 4 meters. The range of ETDRS is 0 to 100 letters. Stability in visual acuity after treatment interruption indicates longer duration of the drug efficacy
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Timepoint [3]
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Month 12 and Month 24
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Secondary outcome [4]
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Number of Patients With a BCVA Improvement of =1, =5, =10, =15, and =30 Letters From Baseline to Month 12 and Month 24 in the Study Eye
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Assessment method [4]
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BCVA score was based on the number of letters read correctly on the Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart assessed at a starting distance of 4 meters. An increased score indicates improvement in acuity. This outcome assessed the number of participants who had improvement of =1, =5, =10, =15, and =30 letters of visual acuity at month 12 as compared with baseline
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Timepoint [4]
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Month 12 and Month 24
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Secondary outcome [5]
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Number of Patients With a BCVA Value of = 73 Letters (Approximate 20/40 Snellen Chart Equivalent) at Month 12 and Month 24
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Assessment method [5]
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Best Corrected Visual Acuity (BCVA) was measured using Early Treatment Diabetic Retinopathy Study (ETDRS)-like chart at baseline and month 12 while participants were in a sitting position at a testing distance of 4 meters. The range of EDTRS is 0 to 100 letters. BCVA above 73 letters at month 12 and month 24 indicates a positive outcome.
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Timepoint [5]
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Month 12 and Month 24
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Secondary outcome [6]
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Mean Change in Central Reading Center (CRC)-Assessed Central Subfield Thickness (CSFT) From Month 12 and Month 24 Compared to Baseline
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Assessment method [6]
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Retinal thickness was measured using Optical Coherence Tomography (OCT). The images were reviewed by a central reading center to ensure a standardized evaluation
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Timepoint [6]
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Baseline, Month 12 and Month 24
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Secondary outcome [7]
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Mean Change in Patient-reported Outcomes in NEI-VFQ-25 Composite and Subscale Scores at Month 12 and Month 24 Compared to Baseline
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Assessment method [7]
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The survey consists of 25 items representing 11 vision related constructs (general vision, ocular pain, near activities, distance activities, social functioning, mental health, role difficulties, dependency, driving, color vision, peripheral vision) plus a single-item general health rating question. The score of each individual question ranges from 0 (worst) to 100 which indicates the best possible response. The composite score and score of each of each construct also range from 0 to 100 as they are calculated as total scores divided by the number of questions. The higher the values of total scores represent better outcome. Scores per visit and of the change descriptively by visit.
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Timepoint [7]
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Month 12 and Month 24
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Eligibility
Key inclusion criteria
- Male or female patients = 18 years of age
- Diagnosis of visual impairment exclusively due to ME secondary to CRVO
- BCVA score at Screening and Baseline between 73 and 19 letters Early Treatment
Diabetic Retinopathy Study (ETDRS), inclusively (approximate Snellen chart equivalent
of 20/40 and 20/400)
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Minimum age
18
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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
- Uncontrolled blood pressure defined as systolic value of > 160 mm Hg or diastolic
value of > 100 mm Hg at Screening or Baseline.
- Any active periocular or ocular infection or inflammation at Screening or Baseline in
either eye
- Uncontrolled glaucoma at Screening or Baseline or diagnosed within 6 months before
Baseline in either eye
- Use of any systemic antivascular endothelial growth factor (anti-VEGF) drugs within 6
months before Baseline (eg, sorafenib [Nexavar®], sunitinib [Sutent®], bevacizumab
[Avastin®])
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Study design
Purpose of the study
Treatment
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Allocation to intervention
N/A
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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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
1/02/2012
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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
1/03/2015
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Sample size
Target
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Accrual to date
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Final
357
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Parramatta
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Recruitment hospital [2]
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Novartis Investigative Site - Sydney
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Recruitment hospital [3]
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Novartis Investigative Site - Melbourne
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Recruitment hospital [4]
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Novartis Investigative Site - Nedlands
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Recruitment postcode(s) [1]
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2150 - Parramatta
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Recruitment postcode(s) [2]
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2000 - Sydney
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Recruitment postcode(s) [3]
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3002 - Melbourne
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Recruitment postcode(s) [4]
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6009 - Nedlands
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Recruitment outside Australia
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Austria
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Linz
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Austria
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Wien
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Canada
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Alberta
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Canada
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British Columbia
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Canada
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Ontario
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Canada
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Quebec
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Olomouc
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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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Greece
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GR
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Greece
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Greece
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Hungary
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Budapest
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Hungary
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Debrecen
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Ireland
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Dublin 7
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Ireland
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Dublin
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BO
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Italy
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FI
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MI
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RM
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TO
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Amsterdam
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Leiden 2333 ZA
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Nijmegen
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Cataluña
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Galicia
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Bern
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Lausanne
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Zuerich
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Surrey
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Birmingham
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Bristol
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Hull
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Liverpool
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London
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Newcastle upon Tyne
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Plymouth
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United Kingdom
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Southampton
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The present study provided additional efficacy and safety data for 0.5-mg ranibizumab using
as needed (PRN) dosing over 24 months in patients with visual impairment due to macular edema
secondary to Central Retinal Vein Occlusion (CRVO). Spectral domain high-definition optical
coherence tomography (OCT) images was analyzed to gain insights into predictive factors for
disease progression and the possibility of reduced monitoring was assessed in Year 2. The
results of this open-label study provided long-term safety and efficacy data to further guide
recommendations on the use of ranibizumab in this indication.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01535261
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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01535261
Download to PDF