NCT00533520

Evaluation of Dosing Interval of Higher Doses of Ranibizumab

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Brandon G. Busbee, MD · Academic / Other
• Sex: All
• Age: 50 Years – 95 Years
• Healthy volunteers: Accepted

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.

Conditions

• Macular Degeneration
• Choroidal Neovascularization

Interventions

Type	Name	Description
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

Timeline

• Start date: 2007-09-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2007-09-21
• Last updated: 2013-11-25

Locations

1 site across 1 country: United States