Vitreomacular AdhesionPhase 3NCT00798317
Trial of Microplasmin Intravitreal Injection for Non-Surgical Treatment of Focal Vitreomacular Adhesion. The MIVI-TRUST (TG-MV-007) Trial.
A Phase 3 study testing Ocriplasmin 125µg in people with Vitreomacular Adhesion, run by ThromboGenics at 48 sites in 7 countries.
Trial summary
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular… 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?
- Ocriplasmin 125µg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 326 participants
- Where
- 48 sitesin 7 countries
- Study dates
- Dec 2008to Jul 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 6 mm 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
48 sites in 7 countries.
48 sites in 7 countries
United States20 sites
Capital Region Retina
Albany, New York, 12206
Texas Retina Associates
Arlington, Texas, 76012
Retina Research Center
Austin, Texas, 78705
Tufts Medical Center
Boston, Massachusetts, 02111
Retinal Diagnostic Center
Campbell, California, 95008
Southeast Clinical Research Assoicates, PA
Charlotte, North Carolina, 28210
Retina Consultants
Fort Worth, Texas, 76104
Vision Research Center at Truman Medical Center
Kansas City, Missouri, 64108
Deleware Valley Retina Associates
Lawrenceville, New Jersey, 08648
Medeye
Miami, Florida, 33143
Dean A McGee Eye Institute
Oklahoma City, Oklahoma, 73104
Paducah Retinal Center
Paducah, Kentucky, 42001
Retina Specialists
Pensacola, Florida, 32503
Scheie Eye Institute, Penn Eye Care
Philadelphia, Pennsylvania, 19104
Black Hils regional Eye Institute
Rapid City, South Dakota, 57701
Medical Center Ophthalmology Assoc.
San Antonio, Texas, 78240
West Coast Retina Group, Inc
San Francisco, California, 94107
California Retina Consultants
Santa Barbara, California, 93103
Vitreoretinal Associates
Seattle, Washington, 98104
Eye Care Associates
Tyler, Texas, 75701
Germany10 sites
Augenklinik-Universität Bonn
Bonn, D-53127
St. Joseph Stift Bremen Abteilung für Augenheilkunde
Bremen, 28209
Universitäts-Augenklinik Frankfurt am Main
Frankfurt, 60590
Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde
Frankfurt am Main, 65929
Universität Göttingen
Göttingen, 37075
Klinik und Poliklinik für Augenheilkunde
Leipzig, 04103
Philipps Universität Marburg
Marburg, 35037
Augenklinik der Ludwig Maximilians Universität München
München, 80336
Augenärzte am St. Franziskus Hospital
Münster, 48145
Augenklinik im Dietrich-
Neubrandenburg, 17036
Czechia6 sites
University Hospital Brno
Brno, 625 00
University Hospital Hradec Kralove
Hradec Králové, 500 05
University Hospital Olomouc
Olomouc, 775 20
University Hospital Kralovske Vinohrady
Prague, 100 34
Central Military Hospital
Prague, 169 02
Gemini Eye Clinic
Zlín, 760 01
Spain5 sites
Instituto Oftalmología de Alicante (Vissum)
Alicante, 03016
Centro Teknon-Institut de la Macula i de la Retina
Barcelona, 08022
Hospital La Paz
Madrid, 28046
Instituto Technologico de Oftalmologia S.L
Santiago de Compostela, 15705
Hospital General de Valencia
Valencia, 46014
United Kingdom4 sites
St Paul's Eye Unit
Liverpool, L7 8XP
Moorfields Eye Hospital
London, EC1V 2PD
Southampton Eye Unit, Southampton General Hospital
Southampton, SO16 6YD
Wolverhampton Eye Infirmary-New Cross Hospital
Wolverhampton, WV10 0QP
Poland2 sites
Indywidualna Specjalistyczna Praktyka Prywatna
Gdansk, 80-147
Oddział Okulistyczny OSK,
Katowice, 40-760
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.
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.
- Conditions
- Vitreomacular Adhesion
- Being tested
- Ocriplasmin 125µg, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ocriplasmin 125µgDrug
Also called Microplasmin
125µg of ocriplasmin intravitreal injection
PlaceboDrug
Intravitreal injection placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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 Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
Measured: Day 28
Secondary outcomes (1)
Proportion of Subjects With Total Posterior Vitreous Detachment (PVD) at Day 28
Proportion of subjects with total 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 posted26 Nov 2008 (estimated)
- Study startDec 2008
- Primary completionJun 2010
- Study completionJul 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
- NCT00798317
- Sponsor's protocol ID
- TG-MV-007
- Status last verified
- Apr 2014
- First submitted
- 25 Nov 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
- NCT00798317
- Acronym / sponsor ID
- TG-MV-007
- 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
- Jun 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 26 Nov 2008 (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.
This trial will evaluate the safety and efficacy of microplasmin, administered as an intravitreal injection, in subjects with focal vitreomacular adhesion. In previously performed clinical trials, some patients treated with intravitreal microplasmin have had resolution of their underlying condition, including macular hole closure, without need for vitrectomy. This clinical trial is justified because the sponsor believes the potential benefits outweigh the potential risks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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)
- Presence of focal vitreomacular adhesion (i.e., central vitreal adhesion within 6 mm 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 |
|---|---|---|
| Ocriplasmin 125µgAlso: Microplasmin125µg of ocriplasmin intravitreal injection | Drug | Ocriplasmin 125µg |
| PlaceboIntravitreal injection placebo. | Drug | Placebo |
Primary outcome
Proportion of Subjects With Nonsurgical Resolution of Focal Vitreomacular Adhesion at Day 28
Time frame: Day 28
Proportion of subjects with nonsurgical resolution of focal vitreomacular adhesion at Day 28, as determined by masked Central Reading Centre (CRC) Optical Coherence Tomography(OCT)evaluation.
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.
48 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ocriplasmin 125µg in people with Vitreomacular Adhesion, run by ThromboGenics at 48 sites in 7 countries.
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 48 sites in United States, Germany, Czechia, Spain, United Kingdom and 2 more countries. 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 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 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 NCT00798317, 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.