VitrectomyPhase 2MIVI-10NCT01159665
The Purpose of This Study is to Evaluate the Pharmacokinetic Properties of Intravitreal Ocriplasmin Prior to Planned Primary Pars Plana Vitrectomy (PPV)
A Phase 2 study testing ocriplasmin in people with Vitrectomy, run by ThromboGenics at 1 site in Belgium.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitrectomy
- What is being tested?
- ocriplasmin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteBelgium
- Study dates
- Jul 2010to Jan 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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)
Read the 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 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.
- Conditions
- Vitrectomy
- Being tested
- ocriplasmin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ocriplasminDrug
Also called microplasmin
125µg ocriplasmin intravitreal injection
ocriplasminDrug
Also called microplasmin
125µg ocriplasmin intravitreal injection
ocriplasminDrug
Also called microplasmin
125µg ocriplasmin intravitreal injection
ocriplasminDrug
Also called microplasmin
125µg ocriplasmin intravitreal injection
ocriplasminDrug
Also called microplasmin
125µg ocriplasmin intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| PPV 5-30 minutes after injection | Experimental | Primary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection Receives: Drug: ocriplasmin |
| PPV 31-60 minutes after injection | Experimental | Primary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection Receives: Drug: ocriplasmin |
| PPV 2-4 hours after injection | Experimental | Primary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection Receives: Drug: ocriplasmin |
| PPV 24 hours (+2 hours) after injection | Experimental | Primary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection Receives: Drug: ocriplasmin |
| PPV 7 days (+1 day) after injection | Experimental | Primary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection Receives: Drug: ocriplasmin |
| PPV without injection | No intervention | Control Arm, no ocriplasmin intravitreal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2010 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for VitrectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01159665
- Sponsor's protocol ID
- TG-MV-010
- Acronym
- MIVI-10
- Status last verified
- Apr 2014
- First submitted
- 7 Jul 2010
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 23982845
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01159665
- Acronym / sponsor ID
- MIVI-10 / TG-MV-010
- Conditions
- Vitrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 9 Jul 2010 (estimated)
- Results
- Posted 30 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| PPV 5-30 minutes after injection | Experimental | Drug: ocriplasminPrimary Pars Plana Vitrectomy 5 to 30 minutes after 125µg of ocriplasmin intravitreal injection |
| PPV 31-60 minutes after injection | Experimental | Drug: ocriplasminPrimary Pars Plana Vitrectomy 31 to 60 minutes after 125µg of ocriplasmin intravitreal injection |
| PPV 2-4 hours after injection | Experimental | Drug: ocriplasminPrimary Pars Plana Vitrectomy 2 to 4 hours after 125µg of ocriplasmin intravitreal injection |
| PPV 24 hours (+2 hours) after injection | Experimental | Drug: ocriplasminPrimary Pars Plana Vitrectomy 24 hours (+2 hours)after 125µg of ocriplasmin intravitreal injection |
| PPV 7 days (+1 day) after injection | Experimental | Drug: ocriplasminPrimary Pars Plana Vitrectomy 7 days (+1 day)after 125µg of ocriplasmin intravitreal injection |
| PPV without injection | No intervention | –Control Arm, no ocriplasmin intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ocriplasminAlso: microplasmin125µg ocriplasmin intravitreal injection | Drug | PPV 5-30 minutes after injection |
| ocriplasminAlso: microplasmin125µg ocriplasmin intravitreal injection | Drug | PPV 31-60 minutes after injection |
| ocriplasminAlso: microplasmin125µg ocriplasmin intravitreal injection | Drug | PPV 2-4 hours after injection |
| ocriplasminAlso: microplasmin125µg ocriplasmin intravitreal injection | Drug | PPV 24 hours (+2 hours) after injection |
| ocriplasminAlso: microplasmin125µg ocriplasmin intravitreal injection | Drug | PPV 7 days (+1 day) after injection |
Primary outcome
Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy.
Time frame: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23982845Stalmans 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ocriplasmin in people with Vitrectomy, run by ThromboGenics at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocriplasmin Activity Levels in Vitreous Samples Obtained at the Beginning of Vitrectomy. (time frame: 5-30 minutes, 31-60 minutes, 2-4 hours, 1 day, or 7 days after ocriplasmin injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01159665, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2014.