Efficacy of Ranibizumab Prn Treatment Compared to Aflibercept Bimonthly Intravitreal Injections on Retinal Thickness Stability in Patients With Wet AMD (SALT)
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|ClinicalTrials.gov Identifier: NCT01958918|
Recruitment Status : Completed
First Posted : October 9, 2013
Results First Posted : March 21, 2019
Last Update Posted : March 21, 2019
|Condition or disease||Intervention/treatment||Phase|
|Neovascular Age-related Macular Degeneration||Drug: Ranibizumab Drug: Aflibercept||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||712 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
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.
|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|
1 intravitreal injection monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT signs of wet AMD disease activity
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
2 mg intravitreal injection
Other Name: Eylea®
- 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.
- 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
- 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.
- 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.
- 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.
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
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|