Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy (MIC)
This study has been completed.
Sponsor:
ThromboGenics
Information provided by (Responsible Party):
ThromboGenics
ClinicalTrials.gov Identifier:
NCT00986362
First received: September 28, 2009
Last updated: January 22, 2013
Last verified: April 2012
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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:
- 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 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.
Contacts and Locations
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