Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
MIC
The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
1 other identifier
interventional
24
1 country
1
Brief Summary
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 28, 2009
CompletedFirst Posted
Study publicly available on registry
September 29, 2009
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
February 20, 2014
CompletedDecember 17, 2014
April 1, 2014
1.8 years
September 28, 2009
July 4, 2013
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
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.
Beginning of vitrectomy or after application of suction
Study Arms (2)
Ocriplasmin
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Male or female infants or children 16 years of age or younger
- Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
- Patient with attached vitreous somewhere in posterior pole
- Patient's parent or guardian must be willing and able to comply with follow-up requirements
- Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form
You may not qualify if:
- Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery
- Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
- Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements
- Medical problems that make consistent follow-up over the treatment period uncertain.
- Patient must not have participated in an investigational drug or device study in the prior 30 days
- Female Patients of childbearing potential must not be pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ThromboGenicslead
Study Sites (1)
Associated Retina Consultants
Royal Oak, Michigan, 48073, United States
MeSH Terms
Interventions
Results Point of Contact
- Title
- Dr. Petra Kozma-Wiebe
- Organization
- ThromboGenics NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 28, 2009
First Posted
September 29, 2009
Study Start
February 1, 2010
Primary Completion
December 1, 2011
Study Completion
April 1, 2012
Last Updated
December 17, 2014
Results First Posted
February 20, 2014
Record last verified: 2014-04