Trial | NCT00533520  Report issue

Official Title

Evaluation of Dosing Interval of Higher Doses of Ranibizumab

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    37
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.
Study Started
Sep 30
2007
Primary Completion
Nov 30
2013
Study Completion
Nov 30
2013
Last Update
Nov 25
2013
Estimate

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 names: rhuFab V2

0.5mg ranibizumab Active Comparator

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.

1.0mg ranibizumab Active Comparator

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.

2.0mg ranibizumab Active Comparator

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.

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
No Results Posted