Ignite Creation Date:
2025-12-18 @ 9:04 AM
Ignite Modification Date:
2025-12-18 @ 9:04 AM
Study NCT ID:
NCT00626782
Status:
None
Last Update Posted:
2018-03-22 00:00:00
First Post:
2008-02-20 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lucentis Versus Mitomycin C During Glaucoma Surgery
Sponsor:
None
Organization:
Study Overview
Official Title:
Lucentis Versus Mitomycin C as Adjunctive Agent During Trabeculectomy Surgery
Status:
None
Status Verified Date:
2018-02
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:
None
Brief Summary:
This is an open-label, single center trial with two arms for patients who underwent guarded filtration surgery to control glaucoma. The control will consist of patients randomly assigned to receive inter-operative mitomycin C 0.4 mg/ml which is applied in a standard fashion with a soaked pledget inserted in the sub-tenon's space during surgery. The study arm will consist of patients randomly assigned to receive a sub-tenon injection of Ranibizumab 0.5 mg/0.05mL with a 30 gauge needle on a tuberculin syringe at the termination of the surgery. No mitomycin C will be applied.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
Post operative follow-up will consist of a minimum of 6 visits during a one year period.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?: