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

Vitrectomy Clinical Trial

— MIC  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00986362
• Other study ID #: TG-MV-009
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2009
• Last updated: December 2, 2014
• Start date: February 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitrectomy

Intervention

Drug:
• Ocriplasmin
175µg ocriplasmin intravitreal injection
• Placebo
Placebo intravitreal injection

Locations

Country	Name	City	State
United States	Associated Retina Consultants	Royal Oak,	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).	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.	Beginning of vitrectomy or after application of suction	No