Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration

NCT ID: NCT00504959

Last Updated: 2016-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

234 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2010-01-31

Brief Summary

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This extension study will investigate the long-term safety and tolerability of multiple intravitreal injections of ranibizumab administered to patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration who have been previously treated in either of the two ongoing ranibizumab studies CRFB002A2302 (EXCITE) or CRFB002A2303 (SUSTAIN

Detailed Description

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Conditions

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Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

ranibizumab

Group Type EXPERIMENTAL

ranibizumab

Intervention Type DRUG

Interventions

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ranibizumab

Intervention Type DRUG

Other Intervention Names

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rhuFab V2, Lucentis

Eligibility Criteria

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Inclusion Criteria

* Completion of 12-month treatment period of study CRFB002A2302 (EXCITE) or CRFB002A2303

Exclusion Criteria

* Concurrent participation in another clinical trial, i.e. use of other investigational drugs
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis

Role: STUDY_CHAIR

Board of Hacettepe University , Ankara, turkey

Locations

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Novartis Investigational Site

Melbourne, , Australia

Site Status

Novartis Investigative Site

Laken, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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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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Düsseldorf, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Marburg, , Germany

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München, , Germany

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Siegburg, , Germany

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Tübingen, , Germany

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Würzburg, , Germany

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Budapest, , Hungary

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Debrecen, , Hungary

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Amsterdam, , Netherlands

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Nijmegen, , Netherlands

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Coimbra, , Portugal

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Porto, , Portugal

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Alicante, , Spain

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Barcelona, , Spain

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Madrid, , Spain

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Santiago de Compostela, , Spain

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Valencia, , Spain

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Ankara, , Turkey (Türkiye)

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Bristol, , United Kingdom

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Southampton, , United Kingdom

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West Midlands, , United Kingdom

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Wolverhampton, , United Kingdom

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Countries

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Australia Belgium Germany Hungary Israel Netherlands Portugal Spain Turkey (Türkiye) United Kingdom

References

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Silva R, Axer-Siegel R, Eldem B, Guymer R, Kirchhof B, Papp A, Seres A, Gekkieva M, Nieweg A, Pilz S; SECURE Study Group. The SECURE study: long-term safety of ranibizumab 0.5 mg in neovascular age-related macular degeneration. Ophthalmology. 2013 Jan;120(1):130-9. doi: 10.1016/j.ophtha.2012.07.026. Epub 2012 Sep 25.

Reference Type DERIVED
PMID: 23021093 (View on PubMed)

Other Identifiers

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CRFB002A2402

Identifier Type: -

Identifier Source: org_study_id

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