Vitreomacular AdhesionPhase 3NCT00781859
Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-006) Trial.
A Phase 3 study testing 125 µg Ocriplasmin in people with Vitreomacular Adhesion, run by ThromboGenics at 41 sites in United States.
Trial summary
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vitreomacular Adhesion
- What is being tested?
- 125 µg Ocriplasmin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 41 sitesUnited States
- Study dates
- Dec 2008to Apr 2010
- Phase
- Phase 3
- 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
- Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
Who cannot join
- Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye.
- 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 OCT and/or fluorescein angiogram in the study eye.
- Subjects with macular hole diameter > 400 μm 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).
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
University of Michigan-Kellogg Eye Center
Ann Arbor, Michigan, 48105
Southeast Retina Center, PC
Augusta, Georgia, 30909
Rocky Mountain Lions Eye Institute
Aurora, Colorado, 80045-0510
Austin Retina Associates
Austin, Texas, 78705
Maine Vitreoretinal Consultants, LLC, PA
Bangor, Maine, 04401
Retina Vitreous Associate Medical Group
Beverly Hills, California, 90211
Pennsylvania Retina Specialists, P.C.
Camp Hill, Pennsylvania, 17011
Rush University Med. Ctr
Chicago, Illinois, 60612
Colorado Retina Associates, PC
Denver, Colorado, 80230
Kresge Eye Institute
Detroit, Michigan, 48201-1423
Duke Eye Center
Durham, North Carolina, 27710
National Ophthalmologic Research Institute
Fort Meyers, Florida, 33912
Vitreo-Retinal Associates
Grand Rapids, Michigan, 49525
Vitroretinal Consultants
Houston, Texas, 77030
VMR Institute
Huntington Beach, California, 92647
Midwest Eye Institute
Indianapolis, Indiana, 46290
Souteastern Retina Associates
Kingsport, Tennessee, 37660
Retina Association of Cleveland
Lakewood, Ohio, 44107
Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS
Lexington, Kentucky, 40536-0284
Jules Stein Eye Institute/UCLA
Los Angeles, California, 90095
Valley Retina Institute, P.A.
McAllen, Texas, 78503
Vitroretinal Surgery PA
Minneapolis, Minnesota, 55435
Retina Vitreous Centre, PA
New Brunswick, New Jersey, 08901
New York Eye and Ear Infirmary
New York, New York, 10003
Columbia University - Harkness Eye Institute
New York, New York, 10032
Retina Vitreous Surgeons of Central NY
New York, New York, 13224
University of Miami-Bascom Palmer Eye Institute- Palm Beach
Palm Beach, Florida, 33418
Southern California Desert Retina Consultants
Palm Springs, California, 92262
Retinal Consultants of AZ
Phoenix, Arizona, 85014
Assocaited Retina Consultants, Ltd.
Phoenix, Arizona, 85020
Allegheny Ophthalmic & Orbital Associates, PC
Pittsburgh, Pennsylvania, 15212
Associated Retina Consultants
Royal Oak, Michigan, 48073
Retinal Consultants Medical Group
Sacramento, California, 95819
Retinal Consultants of San Antonio
San Antonio, Texas, 78240
Sarasota Retina Institute
Sarasota, Florida, 34239
Caroline Eye Associates
Southern Pines, North Carolina, 28387
Retina Association of NJ
Teaneck, New Jersey, 07666
National Retina Institute
Towson, Maryland, 21204
Retina Centers, P.C.
Tucson, Arizona, 85704
Wake Forest University Eye Center
Winston-Salem, North Carolina, 27157
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
About this study
Official title: A Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
- Conditions
- Vitreomacular Adhesion
- Being tested
- 125 µg Ocriplasmin, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
125 µg OcriplasminDrug
Also called microplasmin
125µg ocriplasmin intravitreal injection
PlaceboDrug
Placebo intravitreal injection
| Study group | Role | What they receive |
|---|---|---|
| 125µg Ocriplasmin | Experimental | 125µg intravitreal injection of ocriplasmin Receives: Drug: 125 µg Ocriplasmin |
| Placebo | Placebo comparator | placebo intravitreal injection Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.
The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.
Measured: Day 28
Secondary outcomes (1)
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
The key secondary endpoint of this study was the proportion of subjects with total Posterior Vitreous Detachment (PVD) at Day 28, as determined by masked Investigator assessment of B-scan ultrasound.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startDec 2008
- Primary completionMar 2010
- Study completionApr 2010
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 (4)Papers the sponsor has linked to this study.
- Other trials for Vitreomacular AdhesionStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 326 participants (actual)
Sponsor and investigators
- Lead sponsor
- ThromboGenics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781859
- Sponsor's protocol ID
- TG-MV-006
- Status last verified
- Apr 2014
- First submitted
- 28 Oct 2008
- Last updated
- 17 Dec 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Varma R, Haller JA, Kaiser PK. Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion: Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment (MIVI-TRUST) Trials. JAMA Ophthalmol. 2015 Sep;133(9):997-1004. doi: 10.1001/jamaophthalmol.2015.1746.
PubMed 26068086Folgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395-401. doi: 10.1167/iovs.12-10379.
PubMed 23033391Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823.
PubMed 22894573DeCroos FC, Toth CA, Folgar FA, Pakola S, Stinnett SS, Heydary CS, Burns R, Jaffe GJ. Characterization of vitreoretinal interface disorders using OCT in the interventional phase 3 trials of ocriplasmin. Invest Ophthalmol Vis Sci. 2012 Sep 21;53(10):6504-11. doi: 10.1167/iovs.12-10370.
PubMed 22879421
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 Randomized, Placebo Controlled, Double-masked, Multicenter Trial of Microplasmin Intravitreal Injection for Non-surgical Treatment of Focal Vitreomacular Adhesion
- ClinicalTrials.gov ID
- NCT00781859
- Acronym / sponsor ID
- TG-MV-006
- Conditions
- Vitreomacular Adhesion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- ThromboGenicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Posted 28 Jan 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 125µg Ocriplasmin | Experimental | Drug: 125 µg Ocriplasmin125µg intravitreal injection of ocriplasmin |
| Placebo | Placebo comparator | Drug: Placeboplacebo intravitreal injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6mm Optical Coherence Tomography (OCT) field surrounded by elevation of the posterior vitreous cortex) that in the opinion of the Investigator is related to decreased visual function (such as metamorphopsia, decreased visual acuity, or other visual complaint)
Key exclusion criteria (5 listed)
- Any evidence of proliferative retinopathy (including Proliferative Diabetic Retinopathy (PDR) or other ischemic retinopathies involving vitreoretinal vascular proliferation) or exudative Age-Related Macular Degeneration (AMD) or retinal vein occlusion in the study eye.
- 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 OCT and/or fluorescein angiogram in the study eye.
- Subjects with macular hole diameter > 400 μm 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).
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 |
|---|---|---|
| 125 µg OcriplasminAlso: microplasmin125µg ocriplasmin intravitreal injection | Drug | 125µg Ocriplasmin |
| PlaceboPlacebo intravitreal injection | Drug | Placebo |
Primary outcome
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28.
Time frame: Day 28
The primary efficacy endpoint was the proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28 post-injection, as determined by masked Central Reading Center (CRC) Optical Coherence Tomography (OCT) evaluation. Any subjects who had a creation of an anatomical defect (i.e. retinal hole, retinal detachment) that resulted in loss of vision or that required additional intervention were not counted as successes for this primary endpoint.
1 secondary outcome
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Time frame: Day 28
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 26068086Varma R, Haller JA, Kaiser PK. Improvement in Patient-Reported Visual Function After Ocriplasmin for Vitreomacular Adhesion: Results of the Microplasmin for Intravitreous Injection-Traction Release Without Surgical Treatment (MIVI-TRUST) Trials. JAMA Ophthalmol. 2015 Sep;133(9):997-1004. doi: 10.1001/jamaophthalmol.2015.1746.
- Derived from this study: PubMed 23033391Folgar FA, Toth CA, DeCroos FC, Girach A, Pakola S, Jaffe GJ. Assessment of retinal morphology with spectral and time domain OCT in the phase III trials of enzymatic vitreolysis. Invest Ophthalmol Vis Sci. 2012 Oct 25;53(11):7395-401. doi: 10.1167/iovs.12-10379.
- Derived from this study: PubMed 22894573Stalmans P, Benz MS, Gandorfer A, Kampik A, Girach A, Pakola S, Haller JA; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012 Aug 16;367(7):606-15. doi: 10.1056/NEJMoa1110823.
- Derived from this study: PubMed 22879421DeCroos FC, Toth CA, Folgar FA, Pakola S, Stinnett SS, Heydary CS, Burns R, Jaffe GJ. Characterization of vitreoretinal interface disorders using OCT in the interventional phase 3 trials of ocriplasmin. Invest Ophthalmol Vis Sci. 2012 Sep 21;53(10):6504-11. doi: 10.1167/iovs.12-10370.
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.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 125 µg Ocriplasmin in people with Vitreomacular Adhesion, run by ThromboGenics at 41 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 5 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 41 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 28 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 Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28. (time frame: Day 28). 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 NCT00781859, which also lists 4 linked publications.
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.