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

March 2, 2016 updated by: Novartis

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)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

234

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Melbourne, Australia
        • Novartis Investigational site
  • Belgium
      • Laeken, Belgium
        • Novartis Investigative Site
      • Leuven, Belgium
        • Novartis Investigative Site
      • Liege, Belgium
        • Novartis Investigative Site
  • Germany
      • 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
  • Hungary
      • Budapest, Hungary
        • Novartis Investigative Site
      • Debrecen, Hungary
        • Novartis Investigative Site
  • Israel
      • Petach-Tikva, Israel
        • Novartis Investigative Site
      • Tel - Hashomer, Israel
        • Novartis Investigative Site
      • Tel-Aviv, Israel
        • Novartis Investigative Site
  • Netherlands
      • Amsterdam, Netherlands
        • Novartis Investigative Site
      • Nijmegen, Netherlands
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal
        • Novartis Investigative Site
      • Porto, Portugal
        • Novartis Investigative Site
  • Spain
      • 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
  • Turkey
      • Ankara, Turkey
        • Novartis Investigative Site
  • United Kingdom
      • Bristol, United Kingdom
        • Novartis Investigative Site
      • Southampton, United Kingdom
        • Novartis Investigative Site
      • West Midlands, United Kingdom
        • Novartis Investigative Site
      • Wolverhampton, United Kingdom
        • Novartis Investigative Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 1
ranibizumab
Drug: ranibizumab
Other Names:
  • rhuFab V2, Lucentis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis

Investigators

  • Study Chair: Novartis, Board of Hacettepe University , Ankara, turkey

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (ACTUAL)

January 1, 2010

Study Completion (ACTUAL)

January 1, 2010

Study Registration Dates

First Submitted

July 19, 2007

First Submitted That Met QC Criteria

July 19, 2007

First Posted (ESTIMATE)

July 20, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

March 4, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRFB002A2402

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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