Back to resultsEfficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD (SALT)
Primary Purpose
Neovascular Age-related Macular Degeneration
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Ranibizumab
Aflibercept
Sponsored by
About this trial
This is an interventional treatment trial for Neovascular Age-related Macular Degeneration focused on measuring wet age-related macular degeneration (AMD), ranibizumab, aflibercept, Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT)
Eligibility Criteria
Key Inclusion Criteria:
- Visual impairment predominantly due to neovascular AMD Active
- Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion
Key Exclusion Criteria:
- Stroke or myocardial infarction less than 3 Months prior to study entry
- Active injection or inflammation of either eye at the time of study entry
- Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
Sites / Locations
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
- Novartis Investigative Site
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ranibizumab
Aflibercept
Arm Description
1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months
Outcomes
Primary Outcome Measures
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.
Secondary Outcome Measures
Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12
Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity
IREST at Month 12
Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.
National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12
Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.
Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)
Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.
Full Information
NCT ID
NCT01958918
First Posted
October 7, 2013
Last Updated
December 12, 2018
Sponsor
Novartis Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01958918
Brief Title
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
Acronym
SALT
Official Title
A 12-month, Phase IV, Randomized, Open Label, Multicenter Study to Compare Efficacy of 0.5 mg Ranibizumab Pro re Nata (PRN) Versus 2 mg Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability Till Month 6 of Treatment and Explore Functional Outcomes up to Month 12 in Patients With Neovascular (Wet) Age-related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
October 23, 2013 (Actual)
Primary Completion Date
November 22, 2016 (Actual)
Study Completion Date
May 29, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.
Detailed Description
Patients attended 14 scheduled study visits during 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-related Macular Degeneration
Keywords
wet age-related macular degeneration (AMD), ranibizumab, aflibercept, Best Corrected Visual Acuity (BCVA), Spectral Domain Optical Coherence Tomography (SD-OCT)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
The reading center was masked for treatment assignment in order to ensure unbiased evaluation of the primary, secondary and exploratory objectives that were determined by SDOCT, autofluorescence imaging, and microperimetry and multifocal ERG (where available).
When communicating with the reading center study centers had to be vigilant not to unblind the reading center to the treatment.
Site staff performing the assessments of BCVA, contrast sensitivity (where possible), VFQ25 and IReST (reading speed) were also masked to the identity of the treatment.
The central laboratory used for analysis of all specimens collected for biomarker assessment were blinded to the identity of the treatment.
Allocation
Randomized
Enrollment
712 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ranibizumab
Arm Type
Experimental
Arm Description
1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
Arm Title
Aflibercept
Arm Type
Active Comparator
Arm Description
1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months
Intervention Type
Drug
Intervention Name(s)
Ranibizumab
Other Intervention Name(s)
Lucentis®
Intervention Description
0.5 mg intravitreal injection
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea®
Intervention Description
2 mg intravitreal injection
Primary Outcome Measure Information:
Title
Mean of the Absolute Values of CSRT Difference Month 3 to Month 6
Description
The thickness of the retina was measured by Spectral Domain Optical Coherence Topography (SD-OCT). The mean of the absolute values of the CSRT difference between Month 3 and 4, Month 4 and 5, and Month 5 and 6 was calculated (ie, CSRT fluctuation). A lower average CSRT fluctuation demonstrates greater retinal stability. One eye (study eye) contributed to the analysis.
Time Frame
Month 3, Month 4, Month 5, Month 6
Secondary Outcome Measure Information:
Title
Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12
Description
Visual acuity was assessed in a sitting position with refraction using ETDRS-like visual acuity testing charts at an initial testing distance of 4 meters. A higher score indicates better visual acuity. ETDRS scale ranges from 0-100 letters. A score of 65 to 70 letters represents a low to moderate visual acuity
Time Frame
Month 12
Title
IREST at Month 12
Description
Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.
Time Frame
Month 12
Title
National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12
Description
Vision-related quality of life was assessed by the patient using the National Eye Institute Visual Function Questionnaire. The scores of 12 subscales (general health, general vision, ocular pain, near activities, distance activities, social function, mental health, role difficulties, dependency, driving, color vision, and peripheral vision) were added together for a total (composite) score, which ranged from 0 to 100. A higher score indicates poorer function.
Time Frame
Month 12
Title
Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)
Description
Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.
Time Frame
Month 3 to Month 6, Month 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
Visual impairment predominantly due to neovascular AMD Active
Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion
Key Exclusion Criteria:
Stroke or myocardial infarction less than 3 Months prior to study entry
Active injection or inflammation of either eye at the time of study entry
Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
Novartis Investigative Site
City
Feldkirch
ZIP/Postal Code
A-6807
Country
Austria
Facility Name
Novartis Investigative Site
City
Graz
ZIP/Postal Code
A-8036
Country
Austria
Facility Name
Novartis Investigative Site
City
Linz
ZIP/Postal Code
A-4020
Country
Austria
Facility Name
Novartis Investigative Site
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Novartis Investigative Site
City
Vienna
ZIP/Postal Code
A-1130
Country
Austria
Facility Name
Novartis Investigative Site
City
Laeken
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Novartis Investigative Site
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Novartis Investigative Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Novartis Investigative Site
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
Novartis Investigative Site
City
Dijon
ZIP/Postal Code
21034
Country
France
Facility Name
Novartis Investigative Site
City
Paris cedex 10
ZIP/Postal Code
75010
Country
France
Facility Name
Novartis Investigative Site
City
Paris, Cedex 12
ZIP/Postal Code
F-75571
Country
France
Facility Name
Novartis Investigative Site
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Novartis Investigative Site
City
Regensburg
State/Province
Bavaria
ZIP/Postal Code
93053
Country
Germany
Facility Name
Novartis Investigative Site
City
Bad Rothenfelde
ZIP/Postal Code
49214
Country
Germany
Facility Name
Novartis Investigative Site
City
Bayreuth
ZIP/Postal Code
95444
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
10713
Country
Germany
Facility Name
Novartis Investigative Site
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Novartis Investigative Site
City
Bremen
ZIP/Postal Code
28213
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
ZIP/Postal Code
09113
Country
Germany
Facility Name
Novartis Investigative Site
City
Darmstadt
ZIP/Postal Code
64297
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Novartis Investigative Site
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Novartis Investigative Site
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Novartis Investigative Site
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Novartis Investigative Site
City
Glauchau
ZIP/Postal Code
08371
Country
Germany
Facility Name
Novartis Investigative Site
City
Gottingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Novartis Investigative Site
City
Hagen
ZIP/Postal Code
58097
Country
Germany
Facility Name
Novartis Investigative Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Novartis Investigative Site
City
Homburg
ZIP/Postal Code
66421
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50924
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
ZIP/Postal Code
50935
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Novartis Investigative Site
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Novartis Investigative Site
City
Muelheim
ZIP/Postal Code
45468
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
ZIP/Postal Code
81675
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48145
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Novartis Investigative Site
City
Sulzbach
ZIP/Postal Code
66280
Country
Germany
Facility Name
Novartis Investigative Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Novartis Investigative Site
City
Ulm
ZIP/Postal Code
89075
Country
Germany
Facility Name
Novartis Investigative Site
City
Wolfsburg
ZIP/Postal Code
38442
Country
Germany
Facility Name
Novartis Investigative Site
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Novartis Investigative Site
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Den Bosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Nijmegen
ZIP/Postal Code
6500 HB
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Arendal
ZIP/Postal Code
4800
Country
Norway
Facility Name
Novartis Investigative Site
City
Oslo
ZIP/Postal Code
0264
Country
Norway
Facility Name
Novartis Investigative Site
City
Braga
ZIP/Postal Code
4710243
Country
Portugal
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3000-354
Country
Portugal
Facility Name
Novartis Investigative Site
City
Coimbra
ZIP/Postal Code
3030-163
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1050-078
Country
Portugal
Facility Name
Novartis Investigative Site
City
Lisboa
ZIP/Postal Code
1050-085
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
ZIP/Postal Code
4200 319
Country
Portugal
Facility Name
Novartis Investigative Site
City
Vila Franca de Xira
ZIP/Postal Code
2600-009
Country
Portugal
Facility Name
Novartis Investigative Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434 502
Country
Portugal
Facility Name
Novartis Investigative Site
City
Stockholm
ZIP/Postal Code
112 82
Country
Sweden
Facility Name
Novartis Investigative Site
City
Vasteras
ZIP/Postal Code
72189
Country
Sweden
Facility Name
Novartis Investigative Site
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Novartis Investigative Site
City
Genève
ZIP/Postal Code
1204
Country
Switzerland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD
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