Phase 2
N=24
Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
Vitrectomy
Bottom Line
View on ClinicalTrials.gov: NCT00986362 ↗Enrolled (actual)
24
Serious AEs
16.7%
Results posted
Feb 2014
Primary outcome: Primary: Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). — 50; 62.5 percentage of eyes — p=0.679
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ocriplasmin (Drug); Placebo (Drug)
- Age
- Pediatric
- Sex
- All
- Sponsor
- ThromboGenics
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). |
50; 62.5 | 0.679 |
Summary
To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.
Eligibility 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 retinopathy of prematurity (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.
Data sourced from ClinicalTrials.gov (NCT00986362). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.