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

NCT00504959 | Completed Phase 4

• 1 other identifier: CRFB002A2402
• Study Type: interventional
• Target: 234
• Locations: 10 countries
• Sites: 36

Brief Summary

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

Conditions

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

Keywords

Age-related macular degeneration (AMD),; choroidal neovascularization (CNV),; vascular endothelial growth factor (VEGF)

Outcome Measures

Primary Outcomes (1)

• Safety assessed by incidence and severity of treatment emergent ocular and non-ocular adverse events over 24 month study period with ranibizumab monthly prn (0.5mg/0.05ml)

Secondary Outcomes (1)

• Efficacy assessed by mean change in BCVA from Baseline at M 6, 12, 18, and 24. Number of injections with ranibizumab. Safety assessed by AEs and SAEs leading to premature discont. of study drug, vital signs, and ophthalmic exams.

Study Arms (1)

1

EXPERIMENTAL

ranibizumab

Drug: ranibizumab

Interventions

ranibizumab DRUG

Also known as: rhuFab V2, Lucentis

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Concurrent participation in another clinical trial, i.e. use of other investigational drugs

Sponsors & Collaborators

• Novartis: lead

Study Sites (36)

Novartis Investigational Site

Melbourne, Australia

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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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Novartis Investigative SIte

Ankara, Turkey (Türkiye)

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Bristol, United Kingdom

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Novartis Investigative Site

Southampton, United Kingdom

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Novartis Investigative Site

West Midlands, United Kingdom

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Novartis Investigative Site

Wolverhampton, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 23021093 DERIVED

MeSH Terms

Conditions

Macular Degeneration; Choroidal Neovascularization

Interventions

Ranibizumab

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Novartis

  Board of Hacettepe University , Ankara, turkey

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2007
• First Posted: July 20, 2007
• Study Start: July 1, 2007
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: March 4, 2016

Record last verified: 2016-03

Locations

IL (3); NL (2); DE (13); AU (1); PT (2); HU (2); BE (3); ES (5); TU (1); GB (4)