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 June 2014 by Novartis
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01958918
First received: October 7, 2013
Last updated: June 5, 2014
Last verified: June 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: July 2016
Estimated Primary Completion Date: July 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

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
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 63 Study Locations
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: June 5, 2014
Health Authority: Germany: Paul-Ehrlich-Institut

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

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 20, 2014