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

NCT01159665 | Completed Phase 2 Results

• 1 other identifier: TG-MV-010
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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)

Conditions

Vitrectomy

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (1)

• Time Necessary to Remove the Vitreous From the Eye

  From first start of vitrectomy cutter till the end of core vitrectomy phase

Study Arms (6)

PPV 5-30 minutes after injection

EXPERIMENTAL

Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection

Drug: ocriplasmin

PPV 31-60 minutes after injection

EXPERIMENTAL

Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection

Drug: ocriplasmin

PPV 2-4 hours after injection

EXPERIMENTAL

Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection

Drug: ocriplasmin

PPV 24 hours (+2 hours) after injection

EXPERIMENTAL

Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection

Drug: ocriplasmin

PPV 7 days (+1 day) after injection

EXPERIMENTAL

Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection

Drug: ocriplasmin

PPV without injection

NO INTERVENTION

Control Arm, no ocriplasmin intravitreal injection

Interventions

ocriplasmin DRUG

125µg ocriplasmin intravitreal injection

Also known as: microplasmin

PPV 5-30 minutes after injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• ThromboGenics: lead

Study Sites (1)

University Hospital Leuven

Leuven, B-3000, Belgium

Location

Related Publications (1)

• Stalmans P, Girach A. Vitreous levels of active ocriplasmin following intravitreal injection: results of an ascending exposure trial. Invest Ophthalmol Vis Sci. 2013 Oct 9;54(10):6620-7. doi: 10.1167/iovs.13-11811.

  PMID: 23982845 DERIVED

MeSH Terms

Interventions

microplasmin

Results Point of Contact

• Title: Dr. Petra Kozma-Wiebe
• Organization: ThromboGenics

Petra.kozma@thrombogenics.com

+32 16751310

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: July 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: January 1, 2011
• Last Updated: December 17, 2014
• Results First Posted: January 30, 2013

Record last verified: 2014-04

Locations

BE (1)