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

This study has been completed.
Sponsor:
Collaborator:
Genentech
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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Tennessee Retina:

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

Secondary Outcome Measures:
  • Injection interval: mean time and number of injections [ Time Frame: 24 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00533520

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

No publications provided

Responsible Party: Brandon G. Busbee, MD, Sponsor-Investigator, Tennessee Retina
ClinicalTrials.gov Identifier: NCT00533520     History of Changes
Other Study ID Numbers: FVF4155s
Study First Received: September 19, 2007
Last Updated: November 21, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on April 17, 2014