Phase 2
Completed N=38
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
Vitrectomy
Source: ClinicalTrials.gov NCT01159665 ↗
Enrolled (actual)
38
Serious AEs
10.5%
Results posted
Jan 2013
Primary outcomePrimary: Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. — 11597.711; 8108.726; 2610.563; 496.473 ng/mL
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)
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. |
11597.711; 8108.726; 2610.563; 496.473; 272.370; 272.370 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01159665). 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. Informational only — not medical advice.