VitrectomyPhase 2NCT00412958
A Study of the Safety and Efficacy of Microplasmin to Induce a Posterior Vitreous Detachment (MIVI III)
A Phase 2 study testing Ocriplasmin 25µg, Ocriplasmin 75µg and Ocriplasmin 125µg in people with Vitrectomy, run by ThromboGenics at 20 sites in United States.
Trial summary
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy. 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 25µg, Ocriplasmin 75µg and Ocriplasmin 125µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 125 participants
- Where
- 20 sitesUnited States
- Study dates
- Dec 2006to Oct 2008
- 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
- Patients in whom vitrectomy is indicated
Who cannot join
- Posterior Vitreous Detachment (PVD) present at baseline
- Vitreous hemorrhage
- Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- Have had a vitrectomy in the study eye at any time
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
United States20 sites
Mailing add: New England Eye Center - Tufts
Boston, Massachusetts, 02111
Rush University Med. Ctr
Chicago, Illinois, 60612
Duke Eye Center
Durham, North Carolina, 27710
National Ophtlamic Research Institute
Fort Meyers, Florida, 33912
Vitreoretinal Consultants
Houston, Texas, 77030
VMR Institute
Huntington Beach, California, 92647
Retina Association of Cleveland
Lakewood, Ohio, 44107
Jules Stein Eye Institute/UCLA
Los Angeles, California, 90095
Valley Retina Institute, P.A.
McAllen, Texas, 78503
Vitroretinal Surgery, PA
Minneapolis, Minnesota, 55435
Vanderbilt Eye Institute
Nashville, Tennessee, 37232-8808
Retina Vitreous Centre, PA
New Brunswick, New Jersey, 08901
Columbia University - Harkness Eye Institute
New York, New York, 10032
Retina Vitreous Surgeons of Central NY
New York, New York, 13224
Allegheny Ophthalmic & Orbital Associates, P.C.
Pittsburgh, Pennsylvania, 15212
Retinal Consultants of San Diego
Poway, California, 92064
Associated Retinal Consultants, P.C.
Royal Oak, Michigan, 48073
Retinal Consultants Medical Group
Sacramento, California, 95819
Retina Centers, P.C.
Tucson, Arizona, 85704
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
- Conditions
- Vitrectomy
- Being tested
- Ocriplasmin 25µg, Ocriplasmin 75µg, Ocriplasmin 125µg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocriplasmin 25µgDrug
Also called Microplasmin
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin.
Ocriplasmin 75µgDrug
Also called Microplasmin
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin.
Ocriplasmin 125µgDrug
Also called Microplasmin
Intravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin.
PlaceboDrug
Intravitreal injection of placebo
| Study group | Role | What they receive |
|---|---|---|
| Ocriplasmin 25µg | Experimental | 25µg of ocriplasmin intravitreal injection Receives: Drug: Ocriplasmin 25µg |
| Ocriplasmin 75µg | Experimental | 75µg of ocriplasmin intravitreal injection Receives: Drug: Ocriplasmin 75µg |
| Ocriplasmin 125µg | Experimental | 125µg of ocriplasmin intravitreal injection Receives: Drug: Ocriplasmin 125µg |
| Placebo | Placebo comparator | Intravitreal injection of placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionOct 2008
- Study completionOct 2008
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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412958
- Sponsor's protocol ID
- TG-MV-003
- Status last verified
- Apr 2014
- First submitted
- 18 Dec 2006
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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
- A Multicenter, Randomized, Placebo-Controlled, Double-Masked, Parallel Group, Dose-Ranging Clinical Trial of Intravitreal Microplasmin in Patients Undergoing Surgical Vitrectomy: The MIVI III (Microplasmin For Vitreous Injection III) Trial
- ClinicalTrials.gov ID
- NCT00412958
- Acronym / sponsor ID
- TG-MV-003
- Conditions
- Vitrectomy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Dec 2006 (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.
A multicenter study to compare multiple doses of intravitreal microplasmin in patients undergoing surgical vitrectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Ocriplasmin 25µg | Experimental | Drug: Ocriplasmin 25µg25µg of ocriplasmin intravitreal injection |
| Ocriplasmin 75µg | Experimental | Drug: Ocriplasmin 75µg75µg of ocriplasmin intravitreal injection |
| Ocriplasmin 125µg | Experimental | Drug: Ocriplasmin 125µg125µg of ocriplasmin intravitreal injection |
| Placebo | Placebo comparator | Drug: PlaceboIntravitreal injection of placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in whom vitrectomy is indicated
Key exclusion criteria (4 listed)
- Posterior Vitreous Detachment (PVD) present at baseline
- Vitreous hemorrhage
- Certain vitreoretinal conditions including proliferative disease, rhegmatogenous retinal detachment, and proliferative vitreoretinopathy (PVR)
- Have had a vitrectomy in the study eye at any time
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 |
|---|---|---|
| Ocriplasmin 25µgAlso: MicroplasminIntravitreal injection of 0.1 ml of ocriplasmin solution containing 25µg of ocriplasmin. | Drug | Ocriplasmin 25µg |
| Ocriplasmin 75µgAlso: MicroplasminIntravitreal injection of 0.1 ml of ocriplasmin solution containing 75µg of ocriplasmin. | Drug | Ocriplasmin 75µg |
| Ocriplasmin 125µgAlso: MicroplasminIntravitreal injection of 0.1 ml of ocriplasmin solution containing 125µg of ocriplasmin. | Drug | Ocriplasmin 125µg |
| PlaceboIntravitreal injection of placebo | Drug | Placebo |
Primary outcome
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect
Time frame: Day 7
The primary efficacy endpoint was the proportion of patients achieving total PVD without creation of an anatomical defect (ie, retinal hole, retinal detachment) based on surgeon visualization at the beginning of vitrectomy prior to suction or any other mechanical intervention.
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.
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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.
20 sites 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 25µg, Ocriplasmin 75µg and Ocriplasmin 125µg in people with Vitrectomy, run by ThromboGenics at 20 sites 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 1 inclusion and 4 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 20 sites 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 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?
Proportion of Patients Achieving Total Posterior Vitreous Detachment (PVD) Without Creation of an Anatomical Defect (time frame: Day 7). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.