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

NCT ID: NCT00986362

Last Updated: 2014-12-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2012-04-30

Brief Summary

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

Detailed Description

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Conditions

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Vitrectomy

Keywords

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Safety in pediatrics

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ocriplasmin

Group Type EXPERIMENTAL

Ocriplasmin

Intervention Type DRUG

175µg ocriplasmin intravitreal injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo intravitreal injection

Interventions

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Ocriplasmin

175µg ocriplasmin intravitreal injection

Intervention Type DRUG

Placebo

Placebo intravitreal injection

Intervention Type DRUG

Eligibility Criteria

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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.
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ThromboGenics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Associated Retina Consultants

Royal Oak, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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TG-MV-009

Identifier Type: -

Identifier Source: org_study_id