Status:
COMPLETED
Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
Lead Sponsor:
ThromboGenics
Conditions:
Vitrectomy
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE2
Brief Summary
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00986362
Start Date
February 1 2010
End Date
April 1 2012
Last Update
December 17 2014
Active Locations (1)
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1
Associated Retina Consultants
Royal Oak, Michigan, United States, 48073