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

Phase 2

Completed

• Conditions: Vitrectomy
• Interventions: Drug: Placebo; Drug: Ocriplasmin

• Registration Number: NCT00986362
• Lead Sponsor: ThromboGenics

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-28
• Study First Submitted QC: 2009-09-28
• Study First Posted: 2009-09-29
• Study Start: 2010-02
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Results First Submitted: 2013-07-04
• Results First Submitted QC: 2014-02-18
• Results First Posted: 2014-02-20
• Status Verified: 2014-04
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Ocriplasmin	Ocriplasmin	-

Primary Outcome Measures

Name	Time	Method
Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).	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.

Trial Locations

Locations (1)

Associated Retina Consultants; 🇺🇸 Royal Oak,, Michigan, United States