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

NCT ID: NCT01958918

Last Updated: 2019-03-21

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

712 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-23

Study Completion Date

2017-05-29

Brief Summary

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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.

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Detailed Description

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Patients attended 14 scheduled study visits during 12 months.

Conditions

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Neovascular Age-related Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

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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

Group Type EXPERIMENTAL

Ranibizumab

Intervention Type DRUG

0.5 mg intravitreal injection

Aflibercept

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

Group Type ACTIVE_COMPARATOR

Aflibercept

Intervention Type DRUG

2 mg intravitreal injection

Interventions

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Ranibizumab

0.5 mg intravitreal injection

Intervention Type DRUG

Aflibercept

2 mg intravitreal injection

Intervention Type DRUG

Other Intervention Names

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Lucentis® Eylea®

Eligibility Criteria

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Inclusion Criteria

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Feldkirch, , Austria

Site Status

Novartis Investigative Site

Graz, , Austria

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Novartis Investigative Site

Linz, , Austria

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Salzburg, , Austria

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Vienna, , Austria

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Vienna, , Austria

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Laken, , Belgium

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Leuven, , Belgium

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Glostrup Municipality, , Denmark

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Roskilde, , Denmark

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Créteil, , France

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Dijon, , France

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Paris, , France

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Paris, , France

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Paris, , France

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Regensburg, Bavaria, Germany

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Bad Rothenfelde, , Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bonn, , Germany

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Bremen, , Germany

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Chemnitz, , Germany

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Cologne, , Germany

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Cologne, , Germany

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Darmstadt, , Germany

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Düsseldorf, , Germany

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Essen, , Germany

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Frankfurt, , Germany

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Freiburg im Breisgau, , Germany

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Glauchau, , Germany

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Göttingen, , Germany

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Hagen, , Germany

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Hamburg, , Germany

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Homburg, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Marburg, , Germany

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Mülheim, , Germany

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München, , Germany

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Münster, , Germany

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Münster, , Germany

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Siegburg, , Germany

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Sulzbach, , Germany

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Tübingen, , Germany

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Ulm, , Germany

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Wolfsburg, , Germany

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Würzburg, , Germany

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's-Hertogenbosch, , Netherlands

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Amsterdam, , Netherlands

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Nijmegen, , Netherlands

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Arendal, , Norway

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Oslo, , Norway

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Braga, , Portugal

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Coimbra, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Vila Franca de Xira, , Portugal

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Vila Nova de Gaia, , Portugal

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Novartis Investigative Site

Stockholm, , Sweden

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Västerås, , Sweden

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Novartis Investigative Site

Bern, , Switzerland

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Novartis Investigative Site

Fribourg, , Switzerland

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Novartis Investigative Site

Geneva, , Switzerland

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Countries

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Austria Belgium Denmark France Germany Netherlands Norway Portugal Sweden Switzerland

Other Identifiers

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CRFB002ADE23

Identifier Type: -

Identifier Source: org_study_id

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