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

NCT01958918 | Completed Phase 4 Results

• 1 other identifier: CRFB002ADE23
• Study Type: interventional
• Target: 712
• Locations: 10 countries
• Sites: 68

Brief Summary

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.

Conditions

Neovascular Age-related Macular Degeneration

Keywords

wet age-related macular degeneration (AMD); ranibizumab; aflibercept; Best Corrected Visual Acuity (BCVA); Spectral Domain Optical Coherence Tomography (SD-OCT)

Outcome Measures

Primary Outcomes (1)

• Mean of the Absolute Values of CSRT Difference Month 3 to 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 Outcomes (4)

• Total Best Corrected Visual Acuity (BCVA) Score Measured in ETDRS Letters at Month 12

  Month 12

• IREST at Month 12

  Month 12

• National Eye Institute Visual Functioning Questionnaire Composite Score (VFQ-25) at Month 12

  Month 12

• Correlations Between CSRT Fluctuation (Month 3 to 6) and Functional Outcomes at Month 12 (Full Analysis Set)

  Month 3 to Month 6, Month 12

Study Arms (2)

Ranibizumab

EXPERIMENTAL

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

Aflibercept

ACTIVE COMPARATOR

1 intravitreal injection monthly for the first 3 months, followed by 1 intravitreal injection every 2 months

Drug: Aflibercept

Interventions

Ranibizumab DRUG

0.5 mg intravitreal injection

Also known as: Lucentis®

Ranibizumab

Aflibercept DRUG

2 mg intravitreal injection

Also known as: Eylea®

Aflibercept

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (68)

Novartis Investigative Site

Feldkirch, A-6807, Austria

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Novartis Investigative Site

Graz, A-8036, Austria

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Novartis Investigative Site

Linz, A-4020, Austria

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Novartis Investigative Site

Salzburg, 5020, Austria

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Novartis Investigative Site

Vienna, 1090, Austria

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Novartis Investigative Site

Vienna, A-1130, Austria

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Novartis Investigative Site

Laken, 1020, Belgium

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Novartis Investigative Site

Leuven, 3000, Belgium

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Novartis Investigative Site

Glostrup Municipality, 2600, Denmark

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Novartis Investigative Site

Roskilde, 4000, Denmark

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Novartis Investigative Site

Créteil, 94000, France

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Novartis Investigative Site

Dijon, 21034, France

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Novartis Investigative Site

Paris, 75010, France

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Novartis Investigative Site

Paris, 75015, France

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Novartis Investigative Site

Paris, F-75571, France

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Novartis Investigative Site

Regensburg, Bavaria, 93053, Germany

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Novartis Investigative Site

Bad Rothenfelde, 49214, Germany

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Novartis Investigative Site

Bayreuth, 95444, Germany

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Novartis Investigative Site

Berlin, 10713, Germany

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Novartis Investigative Site

Berlin, 12203, Germany

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Novartis Investigative Site

Bonn, 53127, Germany

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Novartis Investigative Site

Bremen, 28213, Germany

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Novartis Investigative Site

Chemnitz, 09113, Germany

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Novartis Investigative Site

Cologne, 50924, Germany

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Novartis Investigative Site

Cologne, 50935, Germany

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Novartis Investigative Site

Darmstadt, 64297, Germany

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Novartis Investigative Site

Düsseldorf, 40225, Germany

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Novartis Investigative Site

Essen, 45147, Germany

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Novartis Investigative Site

Frankfurt, 60590, Germany

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Novartis Investigative Site

Freiburg im Breisgau, 79106, Germany

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Novartis Investigative Site

Glauchau, 08371, Germany

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Novartis Investigative Site

Göttingen, 37075, Germany

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Novartis Investigative Site

Hagen, 58097, Germany

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Novartis Investigative Site

Hamburg, 20246, Germany

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Novartis Investigative Site

Homburg, 66421, Germany

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Novartis Investigative Site

Kiel, 24105, Germany

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Novartis Investigative Site

Leipzig, 04103, Germany

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Novartis Investigative Site

Mainz, 55131, Germany

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Novartis Investigative Site

Marburg, 35039, Germany

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Novartis Investigative Site

Mülheim, 45468, Germany

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Novartis Investigative Site

München, 81675, Germany

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Novartis Investigative Site

Münster, 48145, Germany

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Novartis Investigative Site

Münster, 48149, Germany

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Novartis Investigative Site

Siegburg, 53721, Germany

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Novartis Investigative Site

Sulzbach, 66280, Germany

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Novartis Investigative Site

Tübingen, 72076, Germany

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Novartis Investigative Site

Ulm, 89075, Germany

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Novartis Investigative Site

Wolfsburg, 38442, Germany

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Novartis Investigative Site

Würzburg, 97080, Germany

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Novartis Investigative Site

's-Hertogenbosch, 5223 GZ, Netherlands

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Novartis Investigative Site

Amsterdam, 1105 AZ, Netherlands

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Novartis Investigative Site

Nijmegen, 6500 HB, Netherlands

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Novartis Investigative Site

Arendal, 4800, Norway

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Novartis Investigative Site

Oslo, 0264, Norway

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Novartis Investigative Site

Braga, 4710243, Portugal

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Novartis Investigative Site

Coimbra, 3000-354, Portugal

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Novartis Investigative Site

Coimbra, 3030-163, Portugal

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Novartis Investigative Site

Lisbon, 1050-078, Portugal

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Novartis Investigative Site

Lisbon, 1050-085, Portugal

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Novartis Investigative Site

Porto, 4099-001, Portugal

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Novartis Investigative Site

Porto, 4200 319, Portugal

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Novartis Investigative Site

Vila Franca de Xira, 2600-009, Portugal

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Novartis Investigative Site

Vila Nova de Gaia, 4434 502, Portugal

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Novartis Investigative Site

Stockholm, 112 82, Sweden

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Novartis Investigative Site

Västerås, 72189, Sweden

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Novartis Investigative Site

Bern, 3010, Switzerland

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Novartis Investigative Site

Fribourg, 1708, Switzerland

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Novartis Investigative Site

Geneva, 1204, Switzerland

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MeSH Terms

Interventions

Ranibizumab; aflibercept

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharma AG

Novartis.email@novartis.com

+41613241111

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The reading center was masked for treatment assignment in order to ensure unbiased evaluation of the primary, secondary and exploratory objectives that were determined by SDOCT, autofluorescence imaging, and microperimetry and multifocal ERG (where available). When communicating with the reading center study centers had to be vigilant not to unblind the reading center to the treatment. Site staff performing the assessments of BCVA, contrast sensitivity (where possible), VFQ25 and IReST (reading speed) were also masked to the identity of the treatment. The central laboratory used for analysis of all specimens collected for biomarker assessment were blinded to the identity of the treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 7, 2013
• First Posted: October 9, 2013
• Study Start: October 23, 2013
• Primary Completion: November 22, 2016
• Study Completion: May 29, 2017
• Last Updated: March 21, 2019
• Results First Posted: March 21, 2019

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5); PT (9); NL (3); NO (2); AU (6); DE (34); BE (2); SE (2); CH (3); DK (2)