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

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ClinicalTrials.gov Identifier: NCT00533520
Recruitment Status : Completed
First Posted : September 21, 2007
Last Update Posted : November 25, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Macular Degeneration Choroidal Neovascularization Drug: ranibizumab Phase 4

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 37 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Study Start Date : September 2007
Primary Completion Date : November 2013
Study Completion Date : November 2013


Arms and Interventions

Arm Intervention/treatment
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.
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: 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.
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: 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.
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


Outcome Measures

Primary Outcome Measures :
  1. Safety - Presence of intraocular inflammation following intravitreal ranibizumab injection [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Injection interval: mean time and number of injections [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00533520


Locations
United States, Tennessee
Tennessee Retina, P.C.
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Brandon G. Busbee, MD
Genentech, Inc.
Investigators
Principal Investigator: Brandon G Busbee, MD Tennessee Retina, P.C,.
More Information

Responsible Party: Brandon G. Busbee, MD, Sponsor-Investigator, Tennessee Retina
ClinicalTrials.gov Identifier: NCT00533520     History of Changes
Other Study ID Numbers: FVF4155s
First Posted: September 21, 2007    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases
Ranibizumab
Immunologic Factors
Physiological Effects of Drugs
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents