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

This study has been completed.
Information provided by (Responsible Party):
Novartis Identifier:
First received: July 19, 2007
Last updated: March 2, 2016
Last verified: March 2016
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 Intervention Phase
Subfoveal Choroidal Neovascularization (CNV)
Secondary to Age-related Macular Degeneration (AMD)
Drug: ranibizumab
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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)

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • 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:
  • 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.

Enrollment: 234
Study Start Date: July 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: ranibizumab
Other Name: rhuFab V2, Lucentis


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00504959

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Sponsors and Collaborators
Study Chair: Novartis Board of Hacettepe University , Ankara, turkey
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Identifier: NCT00504959     History of Changes
Other Study ID Numbers: CRFB002A2402
Study First Received: July 19, 2007
Last Updated: March 2, 2016

Keywords provided by Novartis:
Age-related macular degeneration (AMD),
choroidal neovascularization (CNV),
vascular endothelial growth factor (VEGF)

Additional relevant MeSH terms:
Neoplasm Metastasis
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Neoplastic Processes
Pathologic Processes
Retinal Degeneration
Retinal Diseases
Eye Diseases
Choroid Diseases
Uveal Diseases
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents processed this record on April 28, 2017