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: April 4, 2014
Last verified: April 2014
  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: Ocriplasmin
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:
  • 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.


Enrollment: 24
Study Start Date: February 2010
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ocriplasmin Drug: Ocriplasmin
175µg ocriplasmin 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 retinopathy of prematurity (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Results First Received: July 4, 2013
Last Updated: April 4, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by ThromboGenics:
Safety in pediatrics

ClinicalTrials.gov processed this record on August 18, 2014