The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

ThromboGenics1 site in 1 country24 target enrollmentFebruary 2010

ConditionsVitrectomy

InterventionsPlacebo Ocriplasmin

DrugsOcriplasmin Placebo

Overview

Phase: Phase 2
Intervention: Placebo
Conditions: Vitrectomy
Sponsor: ThromboGenics
Enrollment: 24
Locations: 1
Primary Endpoint: Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Registry

clinicaltrials.gov

Start Date

February 2010

End Date

April 2012

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

ThromboGenics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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.

Arms & Interventions

Placebo

Intervention: Placebo

Ocriplasmin

Intervention: Ocriplasmin

Outcomes

Primary Outcomes

Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).

Time Frame: Beginning of vitrectomy or after application of suction

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.