NDLI: Vitreous levels of active ocriplasmin following intravitreal injection: results of an ascending exposure trial.

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Vitreous levels of active ocriplasmin following intravitreal injection: results of an ascending exposure trial.

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Vitreous levels of active ocriplasmin following intravitreal injection: results of an ascending exposure trial.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Girach, Aniz Stalmans, Peter
Description	Country affiliation: Belgium Author Affiliation: Stalmans P ( Department of Ophthalmology, University Hospitals Leuven, Leuven, Belgium.)
Abstract	PURPOSE: To characterize the levels of active ocriplasmin over a period of ascending time points (range, 5 minutes to 7 days) from intravitreal injection of a 125-µg dose to sampling. METHODS: During this 7-week controlled, open-label, phase 2 study, a single intravitreal (125 µg) dose of ocriplasmin was injected into the midvitreous of one eye of each of 34 patients prior to their scheduled primary pars plana vitrectomy. Patients were allocated to vitreous sampling at the beginning of the surgery, which occurred 5 to 30 minutes, 31 to 60 minutes, 2 to 4 hours, 24 ± 2 hours, or 7 ± 1 days after ocriplasmin injection, or to the control group, who received no ocriplasmin injection. RESULTS: With increasing time from ocriplasmin injection to vitreous sampling, mean active ocriplasmin concentration decreased. While at 5 to 30 minutes postinjection, mean active ocriplasmin concentration was 11,597.7 ng/mL, within 31 to 60 minutes from injection the mean active ocriplasmin concentration had reduced to 8108.7 ng/mL; and by 24 hours after injection, half of the patients (2/4) had active ocriplasmin concentrations below the lower limit of quantification (LLQ; <272.4 ng/mL), as did all samples from the day 7 and control groups. No ocular serious adverse events (SAEs) were reported in patients who received ocriplasmin, while three ocular SAEs occurred in the study eye of one patient in the control group (1/38; 2.6%). CONCLUSIONS: Active ocriplasmin concentrations in vitreous samples decreased with increasing time from injection to sample, with enzyme levels in all of the patients in the day 7 group being comparable to those in the control group. (ClinicalTrials.gov number, NCT01159665.).
ISSN	01460404
e-ISSN	15525783
Journal	Investigative Opthalmology & Visual Science
Issue Number	10
Volume Number	54
Language	English
Publisher	Association for Research in Vision and Ophthalmology
Publisher Date	2013-10-09
Publisher Place	United States
Access Restriction	Open
Subject Keyword	Fibrinolysin Pharmacokinetics Fibrinolytic Agents Peptide Fragments Peptide Hydrolases Retinal Diseases Drug Therapy Vitreous Body Metabolism Administration & Dosage Intravitreal Injections Time Factors Clinical Trial, Phase Ii Research Support, Non-u.s. Gov't Discipline Ophthalmology
Content Type	Text
Resource Type	Article
Subject	Ophthalmology Sensory Systems Cellular and Molecular Neuroscience

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