Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy (MIC)
This study has been completed.
Information provided by (Responsible Party):
First received: September 28, 2009
Last updated: February 18, 2014
Last verified: February 2014
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy|
Resource links provided by NLM:
Further study details as provided by ThromboGenics:
Primary Outcome Measures:
- Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). [ Time Frame: Beginning of vitrectomy or after application of suction ] [ Designated as safety issue: No ]Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
|Study Start Date:||February 2010|
|Study Completion Date:||April 2012|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
175µg ocriplasmin intravitreal injection
|Placebo Comparator: Placebo||
Placebo intravitreal injection
Contacts and Locations