Back to resultsEvaluation of Dosing Interval of Higher Doses of Ranibizumab (BGB/IST)
Primary Purpose
Macular Degeneration, Choroidal Neovascularization
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
ranibizumab
Sponsored by
About this trial
This is an interventional treatment trial for Macular Degeneration
Eligibility Criteria
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
Sites / Locations
- Tennessee Retina, P.C.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
0.5mg ranibizumab
1.0mg ranibizumab
2.0mg ranibizumab
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection
Secondary Outcome Measures
Injection interval: mean time and number of injections
Full Information
NCT ID
NCT00533520
First Posted
September 19, 2007
Last Updated
November 21, 2013
Sponsor
Brandon G. Busbee, MD
Collaborators
Genentech, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00533520
Brief Title
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Acronym
BGB/IST
Official Title
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Study Type
Interventional
2. Study Status
Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Brandon G. Busbee, MD
Collaborators
Genentech, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration, Choroidal Neovascularization
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)
8. Arms, Groups, and Interventions
Arm Title
0.5mg ranibizumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
1.0mg ranibizumab
Arm Type
Active Comparator
Arm Description
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.
Arm Title
2.0mg ranibizumab
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
ranibizumab
Other Intervention Name(s)
rhuFab V2
Intervention Description
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
Primary Outcome Measure Information:
Title
Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Injection interval: mean time and number of injections
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brandon G Busbee, MD
Organizational Affiliation
Tennessee Retina, P.C,.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tennessee Retina, P.C.
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
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