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

ThromboGenics

Status and phase: Completed; Phase 2

Conditions: Vitrectomy

Treatments: Drug: Ocriplasmin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00986362

TG-MV-009

Details and patient eligibility

About

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

Enrollment: 24 patients

Sex: All

Ages: Under 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups, including a placebo group

Ocriplasmin

Experimental group

Treatment:

Drug: Ocriplasmin

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo