Vitrectomy Clinical Trial
— MIVI-10Official title:
An Open-Label, Ascending-Exposure-Time, Single Center Trial to Evaluate the Pharmacokinetic Properties of Ocriplasmin (Generic Name of the Molecule Microplasmin) Intravitreal Injection in Subjects Scheduled for Primary Pars Plana Vitrectomy
To evaluate the pharmacokinetic properties of intravitreal ocriplasmin 125 µg dose when administered at different time-points prior to planned primary pars plana vitrectomy (PPV)
Status | Completed |
Enrollment | 38 |
Est. completion date | January 2011 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Male or female subjects aged = 18 - Eye disease for which a primary vitrectomy is indicated - Best Corrected Visual Acuity (BCVA) of 20/800 or better in the non-study eye - Written informed consent obtained from the subject prior to inclusion in the trial Exclusion Criteria: - Proliferative diabetic retinopathy. - Subjects with any vitreous hemorrhage or any other vitreous opacification which precludes either of the following: visualization of the posterior pole by visual inspection OR adequate assessment of the macula by either Optical Coherence Tomography (OCT) and/or fluorescein angiogram in the study eye - Aphakia in the study eye - High myopia (more than 8D) in study eye (unless prior cataract extraction or refractive surgery that makes refraction assessment unreliable for myopia severity approximation, in which case axial length >28 mm is an exclusion). - Subjects with history of rhegmatogenous retinal detachment in the either eye - Subjects who have had ocular surgery, laser photocoagulation treatment, or intravitreal injection(s) in the study eye in the prior three months - Subjects who have had laser photocoagulation to the macula in the study eye at any time - Subjects with uncontrolled glaucoma in the study eye (defined as intraocular pressure = 26 mm Hg in spite of treatment with anti-glaucoma medication) - Subjects with a history of uveitis in either eye. - Subjects who are pregnant or of child-bearing potential not utilizing an acceptable form of contraception. Acceptable methods of birth control include intrauterine device, oral, implanted, or injected contraceptives, and barrier methods with spermicide. - Subjects who, in the Investigators view, will not complete all visits and investigations - Subjects who have participated in an investigational drug trial within the past 30 days - Subjects who have previously participated in this trial |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
ThromboGenics |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Time Necessary to Remove the Vitreous From the Eye | PPV was performed in all subjects. The time necessary to remove the vitreous from the eye, measured from first start of vitrectomy cutter till end of core vitrectomy phase, was calculated. | From first start of vitrectomy cutter till the end of core vitrectomy phase | No |
Primary | Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. | Vitreous samples were obtained at the beginning of vitrectomy in subjects at various times relative to ocriplasmin injection (post-injection), for the determination of ocriplasmin activity (Group 1 [5-30 minutes]; Group 2 [31-60 minutes]; Group 3 [2-4 hours]; Group 4 [24 hours ±2 hours]; Group 5 [7 days ±1 day]. Subjects in Group 6 (control) did not receive the ocriplasmin injection. | 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection | No |
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