Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy
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ClinicalTrials.gov Identifier: NCT00123279 |
Recruitment Status :
Completed
First Posted : July 22, 2005
Last Update Posted : April 7, 2014
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Sponsor:
ThromboGenics
Information provided by:
ThromboGenics
Tracking Information | ||||
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First Submitted Date ICMJE | July 21, 2005 | |||
First Posted Date ICMJE | July 22, 2005 | |||
Last Update Posted Date | April 7, 2014 | |||
Study Start Date ICMJE | December 2004 | |||
Actual Primary Completion Date | February 2007 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction [ Time Frame: Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days ] | |||
Original Primary Outcome Measures ICMJE |
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Change History | ||||
Current Secondary Outcome Measures ICMJE |
The occurrence of any (serious) adverse event [ Time Frame: Throught-out the study ] | |||
Original Secondary Outcome Measures ICMJE |
Best-corrected visual acuity | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy | |||
Official Title ICMJE | A Dose-escalation Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy for Vitreomacular Traction Maculopathy | |||
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 dose/time-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 Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Microplasmin
25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV.
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Study Arms ICMJE |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
60 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | November 2008 | |||
Actual Primary Completion Date | February 2007 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 80 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Belgium, Netherlands | |||
Removed Location Countries | Germany | |||
Administrative Information | ||||
NCT Number ICMJE | NCT00123279 | |||
Other Study ID Numbers ICMJE | TG-MV-001 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Edith Van Dijkman, ThromboGenics | |||
Study Sponsor ICMJE | ThromboGenics | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | ThromboGenics | |||
Verification Date | April 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |