Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2026-03-09 @ 4:51 PM
Study NCT ID:
NCT00533520
Status:
COMPLETED
Last Update Posted:
2013-11-25
First Post:
2007-09-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Sponsor:
Brandon G. Busbee, MD
Organization:
Study Overview
Official Title:
Evaluation of Dosing Interval of Higher Doses of Ranibizumab
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BGB/IST
Brief 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: