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OpenTrials
Completed

NCT Number: NCT00986362

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

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

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Key information

Conditions

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Associated Retina Consultants

Royal Oak, Michigan, 48073, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ocriplasmin

Drug

175µg ocriplasmin intravitreal injection

Placebo

Drug

Placebo intravitreal injection

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

ThromboGenics

Industry

Registry information

Official study 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

Acronym: MIC

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Sep 29, 2009
Registry last updated
Dec 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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