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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00504959
First received: July 19, 2007
Last updated: April 14, 2010
Last verified: April 2010
  Purpose

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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ranibizumab
Drug: ranibizumab
Other Name: rhuFab V2, Lucentis

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00504959

  Show 36 Study Locations
Sponsors and Collaborators
Novartis
Investigators
Study Chair: Novartis Board of Hacettepe University , Ankara, turkey
  More Information

No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00504959     History of Changes
Other Study ID Numbers: CRFB002A2402
Study First Received: July 19, 2007
Last Updated: April 14, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Germany: Federal Institute for Drugs and Medical Devices
Great Britain: Medicines and Healthcare products Regulatory Agency
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Portugal: INFARMED (Instituito Nacional da Farmacia e do Medicamento)
Spain: Agencia Española de Medicamentos y Productos Sanitarios
Turkey: Ministry of Health

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

Additional relevant MeSH terms:
Macular Degeneration
Neoplasm Metastasis
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Neoplastic Processes
Neoplasms
Pathologic Processes
Choroid Diseases
Uveal Diseases
Metaplasia

ClinicalTrials.gov processed this record on September 16, 2014