The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)

Vitrectomy Clinical Trial

— MIVI-10  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01159665
• Other study ID #: TG-MV-010
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2010
• Last updated: December 2, 2014
• Start date: July 2010
• Est. completion date: January 2011

Study information

• Verified date: April 2014
• Source: ThromboGenics
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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)

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 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).

Study drug will be administered in the mid-vitreous by injection. The study eye will be examined after study drug injection to exclude retinal non-perfusion or other complications.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vitrectomy

Intervention

Drug:
• ocriplasmin
125µg ocriplasmin intravitreal injection
• ocriplasmin
125µg ocriplasmin intravitreal injection
• ocriplasmin
125µg ocriplasmin intravitreal injection
• ocriplasmin
125µg ocriplasmin intravitreal injection
• ocriplasmin
125µg ocriplasmin intravitreal injection

Locations

Country	Name	City	State
Belgium	University Hospital Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
ThromboGenics

Country where clinical trial is conducted

Belgium, 

Outcome

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