Evaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Brandon G. Busbee, MD, Tennessee Retina
ClinicalTrials.gov Identifier:
NCT00533520
First received: September 19, 2007
Last updated: November 21, 2013
Last verified: November 2013

September 19, 2007
November 21, 2013
September 2007
November 2013   (final data collection date for primary outcome measure)
Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
To determine if a higher dose (1.0 mg) of ranibizumab is safe [ Time Frame: 12 months ]
Complete list of historical versions of study NCT00533520 on ClinicalTrials.gov Archive Site
Injection interval: mean time and number of injections [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Phase 4 study to test the safety, tolerability and effectiveness of a higher doses (1.0 mg and 2.0 mg) of ranibizumab versus the standard dose (0.5 mg), in adults with age related macular degeneration who have never been treated with ranibizumab. An additional purpose is to determine if the higher doses (1.0 mg and 2.0 mg) of ranibizumab can increase the time between doses beyond that currently needed with the 0.5 mg dose.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Macular Degeneration
  • Choroidal Neovascularization
Drug: ranibizumab
Arm A: 0.5 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Arm B: 1.0 mg ranibizumab on day 0 with retreatment based on defined criteria not to occur sooner than every 28 days Third Arm 2.0mg Arm with retreatment based on defined criteria not to occur sooner than every 28 days
Other Name: rhuFab V2
  • Active Comparator: 0.5mg ranibizumab
    Subjects will be treated with 0.5mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
    Intervention: Drug: ranibizumab
  • Active Comparator: 1.0mg ranibizumab
    Subjects will be treated with 1.0mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
    Intervention: Drug: ranibizumab
  • Active Comparator: 2.0mg ranibizumab
    Subjects will be treated with 2.0 mg ranibizumab at the Day 0 visit and the as needed based on defined retreatment criteria no sooner than every 28 days since last treatment.
    Intervention: Drug: ranibizumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
37
November 2013
November 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treatment naive macular degeneration patients with choroidal neovascularization
  • >50 years old
  • Visual acuity 20/40 to 20/320

Exclusion Criteria:

  • Pregnancy
  • Previous history of thromboembolic event including myocardial infarction or stroke
Both
50 Years to 95 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00533520
FVF4155s
Yes
Brandon G. Busbee, MD, Tennessee Retina
Brandon G. Busbee, MD
Genentech, Inc.
Principal Investigator: Brandon G Busbee, MD Tennessee Retina, P.C,.
Tennessee Retina
November 2013

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