Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy (MIC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00986362
First received: September 28, 2009
Last updated: January 22, 2013
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Vitrectomy
Drug: Microplasmin
Drug: Placebo
Phase 2

Study Type: Interventional
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:
  • Safety will be assessed through the use of reported adverse events, ophthalmologic examinations (including full retinal examinations), B-scan ultrasonography, fundus photography, and fluorescein angiography. Concomitant medications will also be examined. [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Full ophthalmic examination [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]
  • Slit lamp examination [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]
  • Dilated fundus examination [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]
  • B-scan ultrasonography [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]
  • Fundus photography [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]
  • Fluorescein angiography [ Time Frame: From Day 0 to Month 6 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: January 2010
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microplasmin Drug: Microplasmin
175ug microplasmin intravitreal injection
Placebo Comparator: Placebo Drug: Placebo
Placebo intravitreal injection

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female infants or children 16 years of age or younger
  2. Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
  3. Patient with attached vitreous somewhere in posterior pole
  4. Patient's parent or guardian must be willing and able to comply with follow-up requirements
  5. 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:

  1. Patient diagnosed with Stage 1, 2, 3 or 5 ROP at the time of surgery
  2. Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
  3. 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
  4. Medical problems that make consistent follow-up over the treatment period uncertain.
  5. Patient must not have participated in an investigational drug or device study in the prior 30 days
  6. Female Patients of childbearing potential must not be pregnant or lactating.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00986362

Locations
United States, Michigan
Associated Retina Consultants
Royal Oak,, Michigan, United States, 48073
Sponsors and Collaborators
ThromboGenics
  More Information

No publications provided

Responsible Party: ThromboGenics
ClinicalTrials.gov Identifier: NCT00986362     History of Changes
Other Study ID Numbers: TG-MV-009
Study First Received: September 28, 2009
Last Updated: January 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by ThromboGenics:
Safety in pediatrics

ClinicalTrials.gov processed this record on May 23, 2013