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To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 mcg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)
Open-label, ascending-exposure-time, single center trial in which a total of 36 subjects will be enrolled. The time to remove the vitreous will be recorded and a vitreous sample will be obtained at the beginning of vitrectomy for determination of ocriplasmin activity; 32 subjects will receive 125 μg ocriplasmin intravitreal injection prior to vitrectomy and 4 subjects will not receive ocriplasmin intravitreal injection prior to vitrectomy (control arm).
Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary Pars Plana Vitrectomy
ocriplasmin, ocriplasmin, ocriplasmin, ocriplasmin, ocriplasmin
University Hospital Leuven
Published on BioPortfolio: 2014-07-23T21:08:29-0400
The purpose of this study is to observe the anatomical and functional outcomes of ocriplasmin (JETREA®) over a 6-month follow-up period.
In central retinal vein occlusion (CRVO) a blood clot blocks the venous outflow of the entire retinal circulation. This leads to retinal and vitreous hemorrhages, retinal edema and neovasc...
The purpose of this study is to assess the efficacy and safety of up to 3 intravitreal injections of ocriplasmin (0.0625mg or 0.125mg), in subjects with moderately severe to very severe no...
Periocular blockade with 12.5 mm needle is as effective as block with 25 mm needle for patients undergoing Pars Plana Vitrectomy.
The purpose of this study is to compare the amount of intraoperative intraocular bleeding during 23-gauge pars plana vitrectomy (PPV) for diabetic traction retinal detachment (TRD) with an...
To evaluate the effects of ocriplasmin and symptomatic vitreomacular adhesion resolution on visual fixation and macular sensitivity using microperimetry.
To compare the functional and morphologic outcome of patients with vitreomacular traction (VMT) treated with either ocriplasmin treatment or vitrectomy.
To assess the efficacy of ocriplasmin in patients with vitreomacular traction (VMT) syndrome
To assess the effect of ocriplasmin on visual function response (VFR) measured using visual acuity (VA) and vision-related quality of life, and to quantify the association between release of vitreomac...
To investigate the impact of spectral domain optical coherence tomography (SD-OCT) morphological predictive markers on visual acuity and outcome using ocriplasmin for macular hole and vitreomacular tr...
Form of granulomatous uveitis occurring in the region of the pars plana. This disorder is a common condition with no detectable focal pathology. It causes fibrovascular proliferation at the inferior ora serrata.
Inflammation of the pars plana, ciliary body, and adjacent structures.
A region in the substantia nigra located dorsal to the PARS RETICULATA.
A region in the substantia nigra located ventral and lateral to the PARS COMPACTA.
Functional neuroanatomical region of the inferior frontal gyrus consisting of pars opercularis and pars triangularis. It is important in SPEECH and LANGUAGE production. Injuries to Broca area are associated with BROCA APHASIA and APRAXIA.
Pharmacy is the science and technique of preparing as well as dispensing drugs and medicines. It is a health profession that links health sciences with chemical sciences and aims to ensure the safe and effective use of pharmaceutical drugs. The scope of...
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...