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. (see Contacts and Locations)
Verified July 2016 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01958918
First received: October 7, 2013
Last updated: July 19, 2016
Last verified: July 2016
  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: 706
Study Start Date: October 2013
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (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   (Adult, Senior)
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01958918

Contacts
Contact: Novartis Pharmaceuticals +41613241111
Contact: Novartis Pharmaceuticals

  Show 74 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 
Study First Received: October 7, 2013
Last Updated: July 19, 2016
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Novartis:
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

ClinicalTrials.gov processed this record on August 25, 2016