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

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subfoveal Choroidal Neovascularization (CNV) focused on measuring Age-related macular degeneration (AMD),, choroidal neovascularization (CNV),, vascular endothelial growth factor (VEGF)

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Novartis Investigational Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative SIte
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site
  • Novartis Investigative Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

ranibizumab

Outcomes

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.

Full Information

First Posted
July 19, 2007
Last Updated
March 2, 2016
Sponsor
Novartis
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1. Study Identification

Unique Protocol Identification Number
NCT00504959
Brief Title
Safety and Tolerability of Ranibizumab in Patients With Subfoveal Choroidal Neovascularization Secondary to Age-related Macular Degeneration
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
ranibizumab
Intervention Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
rhuFab V2, Lucentis
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Board of Hacettepe University , Ankara, turkey
Official's Role
Study Chair
Facility Information:
Facility Name
Novartis Investigational Site
City
Melbourne
Country
Australia
Facility Name
Novartis Investigative Site
City
Laeken
Country
Belgium
Facility Name
Novartis Investigative Site
City
Leuven
Country
Belgium
Facility Name
Novartis Investigative Site
City
Liege
Country
Belgium
Facility Name
Novartis Investigative Site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative Site
City
Bonn
Country
Germany
Facility Name
Novartis Investigative Site
City
Bremen
Country
Germany
Facility Name
Novartis Investigative Site
City
Chemnitz
Country
Germany
Facility Name
Novartis Investigative Site
City
Duesseldorf
Country
Germany
Facility Name
Novartis Investigative Site
City
Kiel
Country
Germany
Facility Name
Novartis Investigative Site
City
Koeln
Country
Germany
Facility Name
Novartis Investigative Site
City
Leipzig
Country
Germany
Facility Name
Novartis Investigative Site
City
Marburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Muenchen
Country
Germany
Facility Name
Novartis Investigative Site
City
Siegburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Tubingen
Country
Germany
Facility Name
Novartis Investigative Site
City
Wuerzburg
Country
Germany
Facility Name
Novartis Investigative Site
City
Budapest
Country
Hungary
Facility Name
Novartis Investigative Site
City
Debrecen
Country
Hungary
Facility Name
Novartis Investigative Site
City
Petach-Tikva
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel - Hashomer
Country
Israel
Facility Name
Novartis Investigative Site
City
Tel-Aviv
Country
Israel
Facility Name
Novartis Investigative Site
City
Amsterdam
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Nijmegen
Country
Netherlands
Facility Name
Novartis Investigative Site
City
Coimbra
Country
Portugal
Facility Name
Novartis Investigative Site
City
Porto
Country
Portugal
Facility Name
Novartis Investigative Site
City
Alicante
Country
Spain
Facility Name
Novartis Investigative Site
City
Barcelona
Country
Spain
Facility Name
Novartis Investigative Site
City
Madrid
Country
Spain
Facility Name
Novartis Investigative Site
City
Santiago de Compostela
Country
Spain
Facility Name
Novartis Investigative Site
City
Valencia
Country
Spain
Facility Name
Novartis Investigative SIte
City
Ankara
Country
Turkey
Facility Name
Novartis Investigative Site
City
Bristol
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Southampton
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
West Midlands
Country
United Kingdom
Facility Name
Novartis Investigative Site
City
Wolverhampton
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23021093
Citation
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.
Results Reference
derived

Learn more about this trial

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

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