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Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and 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.
 
ClinicalTrials.gov Identifier: NCT00288561
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : June 19, 2008
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE February 7, 2006
First Posted Date  ICMJE February 8, 2006
Last Update Posted Date June 19, 2008
Study Start Date  ICMJE November 2004
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00288561 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Subfoveal Choroidal Neovascularization and Age-Related Macular Degeneration
Official Title  ICMJE Open-Label, Multicenter, Phase II Study Assessing the Safety of Ranibizumab Administered in Conjunction With Photodynamic Therapy With Verteporfin in Patients With Occult or Predominately Classic Subfoveal Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (ARMD)
Brief Summary Ranibizumab is derived from a murine monoclonal anti- vascular endothelial growth factor (VEGF) antibody and can penetrate through the many retinal cell layers following intravitreal injection. The present study is directed towards the assessment of ranibizumab administered on the same day in combination with verteporfin in patients with subfoveal CNV secondary to ARMD
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration (ARMD)
Intervention  ICMJE Drug: ranibizumab
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients 50 years of age or greater who have provided written informed consent

    • Patients with subfoveal choroidal neovascularization lesions secondary to AMD, either predominantly classic or occult with no classic component
    • Patients who have a BCVA score between 73 and 24 letters, inclusively, in the study eye using ETDRS (approximately 20/40 to 20/320)
    • Willing to return for all scheduled visits

Exclusion Criteria:

  • - Patients who have a BCVA of < 34 letters in both eyes (legally blind is defined as bilateral vision below 20/200 or less than 34 letters)
  • Prior treatment in the study eye with verteporfin, external-beam radiation therapy, subfoveal focal laser photocoagulation, vitrectomy, or transpupillary thermotherapy
  • Previous participation in a clinical trial (for either eye) involving anti-angiogenic drugs (pegaptanib, ranibizumab, anecortave acetate, protein kinase C inhibitors, etc.)

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00288561
Other Study ID Numbers  ICMJE CRFB002B2201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis
Study Sponsor  ICMJE Novartis
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Novartis Customer Information Novartis - Including Sites in Germany
PRS Account Novartis
Verification Date June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP