VitrectomyPhase 2MICNCT00986362

Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

A Phase 2 study testing Ocriplasmin in people with Vitrectomy, run by ThromboGenics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients. Read more about this study

Who is it for?: Ages Up to 16 years
Conditions the study is for: Vitrectomy
What is being tested?: Ocriplasmin
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Feb 2010to Apr 2012
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 Up to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female infants or children 16 years of age or younger
Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
Patient with attached vitreous somewhere in posterior pole
Patient's parent or guardian must be willing and able to comply with follow-up requirements
Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form

Who cannot join

Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery
Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements
Medical problems that make consistent follow-up over the treatment period uncertain.
Patient must not have participated in an investigational drug or device study in the prior 30 days
Female Patients of childbearing potential must not be pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

United States1 site

Associated Retina Consultants
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy

To evaluate the safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Conditions: Vitrectomy
Being tested: Ocriplasmin, Placebo
Keywords: Safety in pediatrics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OcriplasminDrug
175µg ocriplasmin intravitreal injection
PlaceboDrug
Placebo intravitreal injection

Study groups in NCT00986362
Study group	Role	What they receive
Ocriplasmin	Experimental	Not described Receives: Drug: Ocriplasmin
Placebo	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.
Measured: Beginning of vitrectomy or after application of suction

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2010Apr 2012

First posted29 Sep 2009 (estimated)
Study startFeb 2010
Primary completionDec 2011
Study completionApr 2012

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.
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: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00986362
Sponsor's protocol ID: TG-MV-009
Acronym: MIC
Status last verified: Apr 2014
First submitted: 28 Sep 2009
Last updated: 17 Dec 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Vitrectomy trials

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: The MIC (Microplasmin In Children) Trial: A Randomized, Placebo-controlled, Double-masked, Clinical Trial of Intravitreal Microplasmin in Infants and Children Scheduled for Vitrectomy
ClinicalTrials.gov ID: NCT00986362
Acronym / sponsor ID: MIC / TG-MV-009
Conditions: Vitrectomy
Keywords: Safety in pediatrics
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: ThromboGenicsIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Dec 2011 (actual)
Study completion: Apr 2012 (actual)
First posted: 29 Sep 2009 (estimated)
Results: Posted 20 Feb 2014

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 safety and preliminary efficacy of intravitreal microplasmin as an adjunct to conventional vitrectomy for the treatment of pediatric patients.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Ocriplasmin	Experimental	Drug: Ocriplasmin
Placebo	Placebo comparator	Drug: Placebo

Who may qualify

Ages: Up to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (5 listed)

Male or female infants or children 16 years of age or younger
Patient must be a suitable candidate for conventional 2-port or 3-port pars plana vitrectomy
Patient with attached vitreous somewhere in posterior pole
Patient's parent or guardian must be willing and able to comply with follow-up requirements
Patient's parent(s) must sign informed parental permission form and in the case of school-age children the patient must sign assent form

Key exclusion criteria (6 listed)

Patient diagnosed with Stage 1, 2, 3 or 5 retinopathy of prematurity (ROP) at the time of surgery
Unclear media, which precludes assessment of the posterior pole such as a cataract or vitreal opacity
Active parental/guardian drug or alcohol use or dependence that, in the opinion of the site Investigator, would interfere with parent's or guardian's adherence to study requirements
Medical problems that make consistent follow-up over the treatment period uncertain.
Patient must not have participated in an investigational drug or device study in the prior 30 days

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
Ocriplasmin175µg ocriplasmin intravitreal injection	Drug	Ocriplasmin
PlaceboPlacebo intravitreal injection	Drug	Placebo

Primary outcome

Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).
Time frame: Beginning of vitrectomy or after application of suction
Percentage of eyes with total macular PVD (to the vascular ridge in eyes with ROP) at the beginning of vitrectomy or after application of suction, as assessed by masked surgeon observation under the operating microscope.

Results and safety

Results posted to the registry on 20 Feb 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ocriplasmin	16	14
Placebo	8	7

Primary outcome: Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD).

Time frame: Beginning of vitrectomy or after application of suction. Number. Unit: percentage of eyes

Measure	Ocriplasmin n = 15	Placebo n = 8
Value	50	62.5

Ocriplasmin vs Placebo: Odds Ratio (OR): 0.613 (95% CI 0.070 to 4.509), p = 0.679, Fisher Exact

Population analysed: Study eyes were analysed according to the Intent-to-Treat (ITT) principle, i.e. as randomised regardless of treatment received. The primary endpoint was evaluated using the Full Analysis Set (FAS), with missing data imputed using the Last Observation Carried Forward (LOCF) method. 1 subject contributed 1 eye to both treatment groups

Adverse events

Time frame: Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from the study drug administration day to the end of study (6 months follow-up visit).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocriplasmin	2 of 16 (12.5%)	15 of 16 (93.8%)	Not reported
Placebo	2 of 8 (25%)	8 of 8 (100%)	Not reported

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.

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RecruitingObservational study
Surgical Procedure Efficiency Evaluation stuDy
Cataract, Vitreous Hemorrhage
RecruitingPhase 3
Treatment of Retinal Detachment in People Who Have Not Had Cataract Surgery With Vitrectomy vs Vitrectomy and Cataract Removal
Rhegmatogenous Retinal Detachment
Not yet recruiting
Vitrectomy Combined With Povidone-Iodine Vitreous Irrigation for Infectious Endophthalmitis
Endophthalmitis, Infectious Endophthalmitis
RecruitingPhase 1/2
Topical Netarsudil for the Prevention of Proliferative Vitreoretinopathy in Patients With Retinal Detachment
Rhegmatogenous Retinal Detachment, Proliferative Vitreoretinopathy

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 United States.

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 5 inclusion and 6 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 United States. 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. Some participants in this study may receive a placebo. 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 20 Feb 2014). 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?

Percentage of Eyes With Total Macular Posterior Vitreous Detachment (PVD). (time frame: Beginning of vitrectomy or after application of suction). 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 NCT00986362.

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.