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Phase 2 N=24 Randomized Double-blind Treatment

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

Vitrectomy

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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