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

This study is currently recruiting participants.
Verified January 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01958918
First received: October 7, 2013
Last updated: January 17, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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:

Primary Outcome Measures:
  • Central retinal thikness stability [ Time Frame: Months 3-6 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 500
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01958918

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

Locations
Austria
Novartis Investigative Site Not yet recruiting
Graz, Austria, A-8036
Novartis Investigative Site Not yet recruiting
Innsbruck, Austria, A-6020
Novartis Investigative Site Not yet recruiting
Linz, Austria, A-4020
Novartis Investigative Site Not yet recruiting
Salzburg, Austria, 5020
Novartis Investigative Site Not yet recruiting
Vienna, Austria, A-1130
Novartis Investigative Site Not yet recruiting
Wien, Austria, 1090
Germany
Novartis Investigative Site Not yet recruiting
Aachen, Germany, 52074
Novartis Investigative Site Not yet recruiting
Bad Rothenfelde, Germany, 49215
Novartis Investigative Site Recruiting
Bayreuth, Germany, 95444
Novartis Investigative Site Not yet recruiting
Bremen, Germany, 28209
Novartis Investigative Site Not yet recruiting
Duesseldorf, Germany, 40225
Novartis Investigative Site Not yet recruiting
Essen, Germany, 45147
Novartis Investigative Site Not yet recruiting
Freiburg, Germany, 79106
Novartis Investigative Site Not yet recruiting
Göttingen, Germany, 37075
Novartis Investigative Site Recruiting
Hagen, Germany, 58097
Novartis Investigative Site Not yet recruiting
Homburg, Germany, 66421
Novartis Investigative Site Not yet recruiting
Kaiserslautern, Germany, 67655
Novartis Investigative Site Recruiting
Koeln, Germany, 50935
Novartis Investigative Site Not yet recruiting
Mainz, Germany, 55131
Novartis Investigative Site Not yet recruiting
Marburg, Germany, 35039
Novartis Investigative Site Not yet recruiting
Muelheim, Germany, 45468
Novartis Investigative Site Not yet recruiting
München, Germany, 81675
Novartis Investigative Site Not yet recruiting
Siegburg, Germany, 53721
Novartis Investigative Site Recruiting
Tübingen, Germany, 72076
Novartis Investigative Site Recruiting
Ulm, Germany, 89075
Novartis Investigative Site Not yet recruiting
Wolfsburg, Germany, 38442
Novartis Investigative Site Not yet recruiting
Würzburg, Germany, 97080
Greece
Novartis Investigative Site Not yet recruiting
Athens, Greece, 17673
Novartis Investigative Site Not yet recruiting
Athens, Greece, GR 12461
Novartis Investigative Site Not yet recruiting
Ioannina, Greece, GR 45500
Novartis Investigative Site Not yet recruiting
Thessaloniki, Greece, GR 54636
Switzerland
Novartis Investigative Site Not yet recruiting
Basel, Switzerland, 4056
Novartis Investigative Site Not yet recruiting
Bern, Switzerland, 3010
Novartis Investigative Site Not yet recruiting
Fribourg, Switzerland, 1708
Novartis Investigative Site Not yet recruiting
Olten, Switzerland, 4600
Novartis Investigative Site Not yet recruiting
Zuerich, Switzerland, 8063
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01958918     History of Changes
Other Study ID Numbers: CRFB002ADE23
Study First Received: October 7, 2013
Last Updated: January 17, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Vision, Low
Vision Disorders
Macular Degeneration
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on April 15, 2014