Status:
COMPLETED
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
Lead Sponsor:
ThromboGenics
Conditions:
Vitrectomy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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)
Detailed Description
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01159665
Start Date
July 1 2010
End Date
January 1 2011
Last Update
December 17 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Leuven
Leuven, Belgium, B-3000