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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00504959
Recruitment Status : Completed
First Posted : July 20, 2007
Last Update Posted : March 4, 2016
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD) Drug: ranibizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 234 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase IV, Long-term, Open-label, Multicenter Extension Study to Evaluate the Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-related Macular Degeneration (AMD)
Study Start Date : July 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: 1
Drug: ranibizumab
Other Name: rhuFab V2, Lucentis

Primary Outcome Measures :
  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 Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00504959

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Novartis Investigational Site
Melbourne, Australia
Novartis Investigative Site
Laeken, Belgium
Novartis Investigative Site
Leuven, Belgium
Novartis Investigative Site
Liege, Belgium
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Bonn, Germany
Novartis Investigative Site
Bremen, Germany
Novartis Investigative Site
Chemnitz, Germany
Novartis Investigative Site
Duesseldorf, Germany
Novartis Investigative Site
Kiel, Germany
Novartis Investigative Site
Koeln, Germany
Novartis Investigative Site
Leipzig, Germany
Novartis Investigative Site
Marburg, Germany
Novartis Investigative Site
Muenchen, Germany
Novartis Investigative Site
Siegburg, Germany
Novartis Investigative Site
Tubingen, Germany
Novartis Investigative Site
Wuerzburg, Germany
Novartis Investigative Site
Budapest, Hungary
Novartis Investigative Site
Debrecen, Hungary
Novartis Investigative Site
Petach-Tikva, Israel
Novartis Investigative Site
Tel - Hashomer, Israel
Novartis Investigative Site
Tel-Aviv, Israel
Novartis Investigative Site
Amsterdam, Netherlands
Novartis Investigative Site
Nijmegen, Netherlands
Novartis Investigative Site
Coimbra, Portugal
Novartis Investigative Site
Porto, Portugal
Novartis Investigative Site
Alicante, Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Santiago de Compostela, Spain
Novartis Investigative Site
Valencia, Spain
Novartis Investigative SIte
Ankara, Turkey
United Kingdom
Novartis Investigative Site
Bristol, United Kingdom
Novartis Investigative Site
Southampton, United Kingdom
Novartis Investigative Site
West Midlands, United Kingdom
Novartis Investigative Site
Wolverhampton, United Kingdom
Sponsors and Collaborators
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Study Chair: Novartis Board of Hacettepe University , Ankara, turkey
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Novartis Identifier: NCT00504959    
Other Study ID Numbers: CRFB002A2402
First Posted: July 20, 2007    Key Record Dates
Last Update Posted: March 4, 2016
Last Verified: March 2016
Keywords provided by Novartis:
Age-related macular degeneration (AMD),
choroidal neovascularization (CNV),
vascular endothelial growth factor (VEGF)
Additional relevant MeSH terms:
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Neoplasm Metastasis
Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Neoplastic Processes
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents