Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00123279
Status:
COMPLETED
Last Update Posted:
2014-04-07
First Post:
2005-07-21
Brief Title:
Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
Sponsor:
ThromboGenics
Organization:
ThromboGenics
Study Overview
Official Title:
A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy
Status:
COMPLETED
Status Verified Date:
2014-04
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:
The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy
Detailed Description:
Study drug will be administered in the mid-vitreous by injection Patients will be enrolled into the cohorts in a sequential dosetime-escalating fashion To ensure that enrolment is evenly balanced across eligible conditions enrolment of any specific underlying disease type into any cohort will be capped at five 5 patients
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?:
None