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

December 12, 2018 updated by: Novartis Pharmaceuticals

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)

The purpose of this study was to compare the efficacy of 0.5 mg ranibizumab versus 2 mg aflibercept bimonthly intravitreal injections on retinal thickness stability.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Patients attended 14 scheduled study visits during 12 months.

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Feldkirch, Austria, A-6807
        • Novartis Investigative Site
      • Graz, Austria, A-8036
        • Novartis Investigative Site
      • Linz, Austria, A-4020
        • Novartis Investigative Site
      • Salzburg, Austria, 5020
        • Novartis Investigative Site
      • Vienna, Austria, 1090
        • Novartis Investigative Site
      • Vienna, Austria, A-1130
        • Novartis Investigative Site
  • Belgium
      • Laeken, Belgium, 1020
        • Novartis Investigative Site
      • Leuven, Belgium, 3000
        • Novartis Investigative Site
  • Denmark
      • Glostrup, Denmark, 2600
        • Novartis Investigative Site
      • Roskilde, Denmark, 4000
        • Novartis Investigative Site
  • France
      • Creteil, France, 94000
        • Novartis Investigative Site
      • Dijon, France, 21034
        • Novartis Investigative Site
      • Paris, France, 75015
        • Novartis Investigative Site
      • Paris cedex 10, France, 75010
        • Novartis Investigative Site
      • Paris, Cedex 12, France, F-75571
        • Novartis Investigative Site
  • Germany
      • Bad Rothenfelde, Germany, 49214
        • Novartis Investigative Site
      • Bayreuth, Germany, 95444
        • Novartis Investigative Site
      • Berlin, Germany, 12203
        • Novartis Investigative Site
      • Berlin, Germany, 10713
        • Novartis Investigative Site
      • Bonn, Germany, 53127
        • Novartis Investigative Site
      • Bremen, Germany, 28213
        • Novartis Investigative Site
      • Chemnitz, Germany, 09113
        • Novartis Investigative Site
      • Darmstadt, Germany, 64297
        • Novartis Investigative Site
      • Duesseldorf, Germany, 40225
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Novartis Investigative Site
      • Frankfurt, Germany, 60590
        • Novartis Investigative Site
      • Freiburg, Germany, 79106
        • Novartis Investigative Site
      • Glauchau, Germany, 08371
        • Novartis Investigative Site
      • Gottingen, Germany, 37075
        • Novartis Investigative Site
      • Hagen, Germany, 58097
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Novartis Investigative Site
      • Homburg, Germany, 66421
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Novartis Investigative Site
      • Koeln, Germany, 50924
        • Novartis Investigative Site
      • Koeln, Germany, 50935
        • Novartis Investigative Site
      • Leipzig, Germany, 04103
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Novartis Investigative Site
      • Marburg, Germany, 35039
        • Novartis Investigative Site
      • Muelheim, Germany, 45468
        • Novartis Investigative Site
      • Muenchen, Germany, 81675
        • Novartis Investigative Site
      • Muenster, Germany, 48149
        • Novartis Investigative Site
      • Muenster, Germany, 48145
        • Novartis Investigative Site
      • Siegburg, Germany, 53721
        • Novartis Investigative Site
      • Sulzbach, Germany, 66280
        • Novartis Investigative Site
      • Tübingen, Germany, 72076
        • Novartis Investigative Site
      • Ulm, Germany, 89075
        • Novartis Investigative Site
      • Wolfsburg, Germany, 38442
        • Novartis Investigative Site
      • Wurzburg, Germany, 97080
        • Novartis Investigative Site
    • Bavaria
      • Regensburg, Bavaria, Germany, 93053
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
        • Novartis Investigative Site
      • Den Bosch, Netherlands, 5223 GZ
        • Novartis Investigative Site
      • Nijmegen, Netherlands, 6500 HB
        • Novartis Investigative Site
  • Norway
      • Arendal, Norway, 4800
        • Novartis Investigative Site
      • Oslo, Norway, 0264
        • Novartis Investigative Site
  • Portugal
      • Braga, Portugal, 4710243
        • Novartis Investigative Site
      • Coimbra, Portugal, 3000-354
        • Novartis Investigative Site
      • Coimbra, Portugal, 3030-163
        • Novartis Investigative Site
      • Lisboa, Portugal, 1050-078
        • Novartis Investigative Site
      • Lisboa, Portugal, 1050-085
        • Novartis Investigative Site
      • Porto, Portugal, 4099-001
        • Novartis Investigative Site
      • Porto, Portugal, 4200 319
        • Novartis Investigative Site
      • Vila Franca de Xira, Portugal, 2600-009
        • Novartis Investigative Site
      • Vila Nova de Gaia, Portugal, 4434 502
        • Novartis Investigative Site
  • Sweden
      • Stockholm, Sweden, 112 82
        • Novartis Investigative Site
      • Vasteras, Sweden, 72189
        • Novartis Investigative Site
  • Switzerland
      • Bern, Switzerland, 3010
        • Novartis Investigative Site
      • Fribourg, Switzerland, 1708
        • Novartis Investigative Site
      • Genève, Switzerland, 1204
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Visual impairment predominantly due to neovascular AMD Active
  • Newly diagnosed, untreated, angiographically documented choroidal neovascularization (CNV) lesion

Key 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
  • Any type of systemic disease (or received treatment for it), including any medical condition (controlled or uncontrolled) that were to be expected to progress, recur, or change to an extent which could bias the assessment of the clinical status of the patient to a significant degree or put the patient at special risk

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Ranibizumab
1 intravitreal injection 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 injection
Other Names:
  • Lucentis®
ACTIVE_COMPARATOR: Aflibercept
1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months
Drug: Aflibercept
2 mg intravitreal injection
Other Names:
  • Eylea®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Month 3, Month 4, Month 5, Month 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Month 12
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.
Month 12
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.
Month 12
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.
Month 3 to Month 6, Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 23, 2013

Primary Completion (ACTUAL)

November 22, 2016

Study Completion (ACTUAL)

May 29, 2017

Study Registration Dates

First Submitted

October 7, 2013

First Submitted That Met QC Criteria

October 7, 2013

First Posted (ESTIMATE)

October 9, 2013

Study Record Updates

Last Update Posted (ACTUAL)

March 21, 2019

Last Update Submitted That Met QC Criteria

December 12, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002ADE23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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