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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)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01958918
First Posted: October 9, 2013
Last Update Posted: November 1, 2017
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.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
  Purpose
This is a 12-month, phase IV, randomized, open label, multicenter study to compare efficacy of 0.5 mg ranibizumab pro re nata treatment versus 2 mg aflibercept bimonthly intravitreal injections on central retinal thickness (CRT) stability as measured by mean CRT fluctuations between month 3 and month 6 of treatment by spectral domain optical coherence tomography (SD-OCT) and explore functional outcomes up to month 12 in patients with neovascular (wet) age-related macular degeneration (AMD). Approximately 500 patients will be randomized in Europe.

Condition Intervention Phase
Visual Impairment Due to Neovascular AMD Drug: Ranibizumab Drug: Aflibercept Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
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)

Resource links provided by NLM:


Further study details as provided by Novartis ( Novartis Pharmaceuticals ):

Primary Outcome Measures:
  • Central retinal thikness stability [ Time Frame: Months 3-6 ]
    Treatment effect of ranibizumab pro re nata ( best corrected visual aquity (BCVA) loss and/or SD-OCT disease activity guided retreatment) versus aflibercept bimonthly regimen on CRT stability as measured by mean CRT fluctuations between month 3 and month 6.


Secondary Outcome Measures:
  • Functional outcomes [ Time Frame: Month 12 ]
    Correlation of functional outcomes at month 12 with retinal stress parameters, defined as significant fluctuations in central retinal thickness, as measured by SD-OCT up to month 6


Enrollment: 712
Actual Study Start Date: October 23, 2013
Study Completion Date: May 29, 2017
Primary Completion Date: November 22, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranibizumab
0.5 mg intravitreal injections of ranibizumab 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 injections of ranibizumab monthly until maximum stable BCVA with retreatment based on BCVA loss and/or SD-OCT disease activity
Active Comparator: Aflibercept
2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)
Drug: Aflibercept
2 mg intravitreal injections of aflibercept monthly for the first 3 months, followed by 2 mg intravitreal injections once every 2 months (current EU SmPC label)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Visual impairment predominantly due to neovascular AMD Active
  • newly diagnosed, untreated, angiographically documented,
  • CNV lesion secondary to neovascular AMD in line with Summary of product characteristics of ranibizumab and aflibercept

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

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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


  Show 68 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01958918     History of Changes
Other Study ID Numbers: CRFB002ADE23
First Submitted: October 7, 2013
First Posted: October 9, 2013
Last Update Posted: November 1, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
neovascular AMD
ranibizumab
aflibercept
BCVA
SD OCT

Additional relevant MeSH terms:
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents