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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT02130024
Registration number
NCT02130024
Ethics application status
Date submitted
27/03/2014
Date registered
2/05/2014
Titles & IDs
Public title
A Comparison of Ranibizumab and Aflibercept for the Development of Geographic Atrophy in (Wet) AMD Patients
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Scientific title
Development of New Geographic Atrophy in Patients With Neovascular (Wet) Age-related Macular Degeneration: a Comparison of Ranibizumab and Aflibercept
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Secondary ID [1]
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CRFB002AAU17
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Universal Trial Number (UTN)
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Trial acronym
RIVAL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Age-Related Macular Degeneration
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Condition category
Condition code
Eye
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Diseases / disorders of the eye
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Other
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ranibizumab 0.5 mg
Treatment: Drugs - Aflibercept 2.0 mg
Experimental: Ranibizumab 0.5 mg - 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
Active comparator: Aflibercept 2.0 mg - 3 monthly loading doses (Baseline, Week 4, and Week 8), followed by an individualised treatment and evaluation regimen according to disease activity \[treat and extend\]
Treatment: Drugs: Ranibizumab 0.5 mg
Administered as an intravitreal injection
Treatment: Drugs: Aflibercept 2.0 mg
Administered as an intravitreal injection
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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 Square-root Area of Geographic Atrophy (GA) From Baseline to Month 24
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Assessment method [1]
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Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.
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Timepoint [1]
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Baseline, Month 24
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Secondary outcome [1]
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Mean Change in Square-root Area of Geographic Atrophy From Baseline to Month 12
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Assessment method [1]
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Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center, where the area of GA was measured. Area was treated as zero if GA was reported as absent (Overall determination of GA presence). Mean change from baseline in GA area was reported in square root-transformed data (mm). One eye (study eye) contributed to the analysis.
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Timepoint [1]
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Baseline, Month 12
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Secondary outcome [2]
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Percentage of Patients With Newly Developed Geographic Atrophy During the Overall 24 Months of the Study
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Assessment method [2]
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Multimodal images of the eye were obtained by trained study site personnel and forwarded to an independent Central Reading Center. A patient was considered to have developed new GA if they did not have any GA at the start of the study period and were subsequently diagnosed with GA during the study period (diagnosis of GA change from "No" to "Yes)." The analysis of new GA development was restricted to only those subjects without GA reported at baseline. One eye (study eye) contributed to the analysis.
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Timepoint [2]
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Baseline, Month 12, Month 24
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Secondary outcome [3]
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Mean Number of Intravitreal Injections From Baseline to Month 12 and to Month 24
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Assessment method [3]
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The number of intravitreal injections was calculated. One eye (study eye) contributed to the analysis.
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Timepoint [3]
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Baseline, Month 12, Month 24
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Secondary outcome [4]
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Mean Change in Best Corrected Visual Acuity (BCVA) From Baseline to Month 12 and to Month 24
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Assessment method [4]
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Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. BCVA change was defined as a change in letters correctly identified from the baseline assessment. A positive change value indicates an improvement in visual acuity, while a negative change value indicates a worsening. One eye (study eye) contributed to the analysis
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Timepoint [4]
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Baseline, Month 12, Month 24
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Secondary outcome [5]
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Mean Change in Central Subfield Foveal Thickness (CSFT) From Baseline to Month 12 and to Month 24
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Assessment method [5]
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CSFT (the average retinal thickness of the circular area within 1 millimeter diameter around the foveal center) was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change value indicates an improvement, while a positive change value indicates a worsening. One eye (study eye) contributed to the analysis
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Timepoint [5]
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Baseline, Month 12, Month 24
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Secondary outcome [6]
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Percentage of Patients Showing no Intraretinal Fluid (IRF)/Subretinal Fluid (SRF)
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Assessment method [6]
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Intraretinal fluid and subretinal fluid was assessed using Optical Coherence Tomography (OCT) and recorded as Present/Absent. One eye (study eye) contributed to the analysis.
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Timepoint [6]
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Month 2, Month 12, Month 24
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Secondary outcome [7]
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Percentage of Patients Showing Greater Than and Equal to 15 Letters Gain for BCVA From Baseline to Month 12 and to Month 24
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Assessment method [7]
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Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis.
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Timepoint [7]
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Baseline, Month 12, Month 24
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Secondary outcome [8]
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Percentage of Patients Showing Less Than and Equal to 15 Letters Loss for BCVA From Baseline to Month 12 and to Month 24
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Assessment method [8]
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Visual acuity was assessed with spectacles or other visual corrective devices in place using logMAR charts and recorded in number of letters correctly identified. A gain in letters correctly identified indicates an improvement in visual acuity, while a loss indicates a worsening. One eye (study eye) contributed to the analysis.
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Timepoint [8]
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Baseline, Month 12, Month 24
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Secondary outcome [9]
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Mean Number of Times a Patient Needed to Return to Monthly Intravitreal Injections Over 24 Months
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Assessment method [9]
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The number of times the patient returned to a monthly injection interval (from an extended interval) at least once during the 24-month study was calculated. One eye (study eye) contributed to the analysis.
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Timepoint [9]
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Month 24
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Secondary outcome [10]
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Mean Change in Vascular Endothelial Growth Factor (VEGF) Plasma Concentration From Baseline to 7 Days After the Second and 7 Days After the Third Mandated Intravitreal Injection of Treatment
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Assessment method [10]
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Blood for VEGF plasma concentration analysis was collected at Baseline and again at 7 days after the injection at Week 4 and 7 days after the injection at Week 8.
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Timepoint [10]
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Baseline, Week 5, Week 9
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Secondary outcome [11]
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Percentage of Patients With Change in Retinal Nerve Fibre Thickness From Baseline to Month 12 and Month 24
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Assessment method [11]
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Retinal nerve fibre thickness was assessed using Optical Coherence Tomography (OCT) and measured in micrometers. A negative change in value (i.e. thinner nerve fibre) indicates nerve damage. One eye (study eye) contributed to the analysis.
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Timepoint [11]
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Baseline, Month 12, Month 24
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Secondary outcome [12]
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Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Cells
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Assessment method [12]
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Anterior cell grade was assessed by the Investigator during slit lamp examination and graded on a 5-point scale: Grade 0=0 cells; Grade 1=1 to 10 cells; Grade 2=11 to 20 cells; Grade 3=21 to 50 cells; Grade 4=\>50 cells. The presence of blood cells (red and white) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. One eye (study eye) contributed to the analysis.
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Timepoint [12]
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Baseline, Week 9
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Secondary outcome [13]
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Percentage of Patients With Ocular Inflammation at Baseline and 7 Days Post-injection Following 3rd Mandated Intravitreal Injection - Anterior Chamber Flare
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Assessment method [13]
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Anterior chamber flare was assessed by the investigator during slit lamp examination and graded on a 5-point scale, with 0 = none; 1 = mild (trace to clearly noticeable, visible); 2 = moderate; 3 = marked; and 4 = severe. The presence of flare (increased protein levels) in the anterior chamber of the eye (the fluid-filled space inside the eye between the iris and the cornea's innermost surface) is a sign of intraocular inflammation. A score of 0 indicates an absence of inflammation. Proportion of patients is reported as a percentage. One eye (study eye) contributed to the analysis.
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Timepoint [13]
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Baseline, Week 9
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Eligibility
Key inclusion criteria
Inclusion criteria:
- Written informed consent.
Inclusion criteria specific to the study eye:
* Diagnosis of active subfoveal Choroidal Neovascularisation (CNV) secondary to wet Age-related Macular Degeneration (AMD);
* Best Corrected Visual Acuity (BCVA) score of 23 letters or more as measured by 3-metre Early Treatment Diabetic Retinopathy Study (ETDRS)-like charts.
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Minimum age
50
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
Exclusion criteria:
* Pregnant, nursing, or at risk of becoming pregnant during the study;
* Inability to comply with the study or follow-up procedures;
* Recent (3 months) stroke or myocardial infarction; uncontrolled hypertension; hypersensitivity to the study treatments or to fluorescein;
* In either eye: active periocular or ocular infection or inflammation; iris neovascularisation; uncontrolled or neovascular glaucoma; or one or more patch of geographic atrophy (GA) as specified in the protocol.
Exclusion criteria specific to the study eye:
* Prior or current treatment with anti-angiogenic drugs or corticosteroids;
* Other eye conditions as specified in the protocol;
* Any intraocular procedure carried out within 2 months before baseline or anticipated within 6 months following baseline.
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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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
11/04/2014
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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
15/11/2017
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Sample size
Target
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Accrual to date
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Final
281
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
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Recruitment hospital [1]
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Novartis Investigative Site - Albury
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Recruitment hospital [2]
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Novartis Investigative Site - Brookvale
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Recruitment hospital [3]
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Novartis Investigative Site - Chatswood
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Recruitment hospital [4]
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Novartis Investigative Site - Hurtsville
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Recruitment hospital [5]
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Novartis Investigative Site - Mona Vale
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Recruitment hospital [6]
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Novartis Investigative Site - Parramatta
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Recruitment hospital [7]
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Novartis Investigative Site - Strathfield
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Recruitment hospital [8]
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Novartis Investigative Site - Sydney
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Recruitment hospital [9]
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Novartis Investigative Site - Westmead
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Recruitment hospital [10]
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Novartis Investigative Site - Caboolture
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Recruitment hospital [11]
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Novartis Investigative Site - Redcliffe
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Recruitment hospital [12]
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Novartis Investigative Site - South Brisbane
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Recruitment hospital [13]
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Novartis Investigative Site - Southport
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Recruitment hospital [14]
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Novartis Investigative Site - Adelaide
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Recruitment hospital [15]
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Novartis Investigative Site - South Launceston
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Recruitment hospital [16]
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Novartis Investigative Site - Clayton
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Recruitment hospital [17]
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Novartis Investigative Site - Malvern
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Recruitment hospital [18]
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Novartis Investigative Site - Parkville,
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Recruitment hospital [19]
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Novartis Investigative Site - Nedlands
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Recruitment hospital [20]
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Novartis Investigative Site - Subiaco
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Recruitment postcode(s) [1]
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2640 - Albury
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Recruitment postcode(s) [2]
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2100 - Brookvale
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Recruitment postcode(s) [3]
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2067 - Chatswood
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Recruitment postcode(s) [4]
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2220 - Hurtsville
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Recruitment postcode(s) [5]
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- Mona Vale
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Recruitment postcode(s) [6]
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2150 - Parramatta
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Recruitment postcode(s) [7]
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2035 - Strathfield
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Recruitment postcode(s) [8]
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2135 - Strathfield
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Recruitment postcode(s) [9]
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2000 - Sydney
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Recruitment postcode(s) [10]
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AUSTRALIA - Sydney
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Recruitment postcode(s) [11]
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2145 - Westmead
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Recruitment postcode(s) [12]
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4510 - Caboolture
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Recruitment postcode(s) [13]
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4020 - Redcliffe
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Recruitment postcode(s) [14]
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4101 - South Brisbane
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Recruitment postcode(s) [15]
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4215 - Southport
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Recruitment postcode(s) [16]
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5000 - Adelaide
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Recruitment postcode(s) [17]
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7249 - South Launceston
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Recruitment postcode(s) [18]
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3168 - Clayton
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Recruitment postcode(s) [19]
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3144 - Malvern
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Recruitment postcode(s) [20]
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3065 - Parkville,
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Recruitment postcode(s) [21]
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6009 - Nedlands
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Recruitment postcode(s) [22]
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6008 - Subiaco
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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
The purpose of this study was to compare the development of new geographic atrophy in patients with wet Age-related Macular Degeneration (AMD) when treated with either ranibizumab or aflibercept over 24 months. Geographic atrophy is an advanced form of AMD that can result in the progressive and irreversible loss of visual function over time.
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Trial website
https://clinicaltrials.gov/study/NCT02130024
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Trial related presentations / publications
Li E, Donati S, Lindsley KB, Krzystolik MG, Virgili G. Treatment regimens for administration of anti-vascular endothelial growth factor agents for neovascular age-related macular degeneration. Cochrane Database Syst Rev. 2020 May 5;5(5):CD012208. doi: 10.1002/14651858.CD012208.pub2. Gillies MC, Hunyor AP, Arnold JJ, Guymer RH, Wolf S, Ng P, Pecheur FL, McAllister IL. Effect of Ranibizumab and Aflibercept on Best-Corrected Visual Acuity in Treat-and-Extend for Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial. JAMA Ophthalmol. 2019 Apr 1;137(4):372-379. doi: 10.1001/jamaophthalmol.2018.6776.
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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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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/24/NCT02130024/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/24/NCT02130024/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT02130024