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Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD (SALT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01958918
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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.

Condition or disease Intervention/treatment Phase
Neovascular Age-related Macular Degeneration Drug: Ranibizumab Drug: Aflibercept Phase 4

Detailed Description:
Patients attended 14 scheduled study visits during 12 months.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 712 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes 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.

Primary Purpose: Treatment
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)
Actual Study Start Date : October 23, 2013
Actual Primary Completion Date : November 22, 2016
Actual Study Completion Date : May 29, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ranibizumab
1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
Drug: Ranibizumab
0.5 mg intravitreal injection
Other Name: Lucentis®

Active Comparator: Aflibercept
1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months
Drug: Aflibercept
2 mg intravitreal injection
Other Name: Eylea®




Primary Outcome Measures :
  1. Mean of the Absolute Values of CSRT Difference Month 3 to Month 6 [ Time Frame: Month 3, Month 4, Month 5, 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 :
  1. Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12 [ Time Frame: 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

  2. IREST at Month 12 [ Time Frame: Month 12 ]
    Number of incorrectly read words (IREST) was assessed using International Reading Speed Texts (IResT) and measured in words per minute.

  3. National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12 [ Time Frame: 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.

  4. Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set) [ Time Frame: Month 3 to Month 6, Month 12 ]
    Correlation coefficient calculated based on Pearson's correlation between each corresponding parameter and CSRT stability.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01958918


Locations
Show Show 68 study locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01958918    
Other Study ID Numbers: CRFB002ADE23
First Posted: October 9, 2013    Key Record Dates
Results First Posted: March 21, 2019
Last Update Posted: March 21, 2019
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
wet age-related macular degeneration (AMD)
ranibizumab
aflibercept
Best Corrected Visual Acuity (BCVA)
Spectral Domain Optical Coherence Tomography (SD-OCT)
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Ranibizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents