We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00533520
First Posted: September 21, 2007
Last Update Posted: November 25, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
Brandon G. Busbee, MD, Tennessee Retina
  Purpose
Evaluation of Dosing Interval of Higher Doses of Ranibizumab for patients with wet age-related macular degeneration (AMD).

Condition Intervention Phase
Macular Degeneration Choroidal Neovascularization Drug: ranibizumab Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Dosing Interval of Higher Doses of Ranibizumab

Resource links provided by NLM:


Further study details as provided by Brandon G. Busbee, MD, Tennessee Retina:

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

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

Enrollment: 37
Study Start Date: September 2007
Study Completion Date: November 2013
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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 Submitted: September 19, 2007
First Posted: September 21, 2007
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