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The objective of this trial is to evaluate the safety and efficacy of intravitreal microplasmin 125µg dose in subjects wiht focal vitreomacular adhesion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 125µg Ocriplasmin | Experimental | 125µg intravitreal injection of ocriplasmin |
|
| Placebo | Placebo Comparator | placebo intravitreal injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 125 µg Ocriplasmin | Drug | 125µg ocriplasmin intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of AZ | Phoenix | Arizona | 85014 | United States | ||
| Assocaited Retina Consultants, Ltd. |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26068086 | Derived | 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. | |
| 23033391 |
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First patient was recruited on 30 Dec 2008 and last patient completed the study on 17 March 2010
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin 125µg | 125µg ocriplasmin intravitreal injection |
| FG001 | Placebo | Intravitreal injection of placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo intravitreal injection |
|
| Phoenix |
| Arizona |
| 85020 |
| United States |
| Retina Centers, P.C. | Tucson | Arizona | 85704 | United States |
| Retina Vitreous Associate Medical Group | Beverly Hills | California | 90211 | United States |
| VMR Institute | Huntington Beach | California | 92647 | United States |
| Jules Stein Eye Institute/UCLA | Los Angeles | California | 90095 | United States |
| Southern California Desert Retina Consultants | Palm Springs | California | 92262 | United States |
| Retinal Consultants Medical Group | Sacramento | California | 95819 | United States |
| Rocky Mountain Lions Eye Institute | Aurora | Colorado | 80045-0510 | United States |
| Colorado Retina Associates, PC | Denver | Colorado | 80230 | United States |
| National Ophthalmologic Research Institute | Fort Meyers | Florida | 33912 | United States |
| University of Miami-Bascom Palmer Eye Institute- Palm Beach | Palm Beach | Florida | 33418 | United States |
| Sarasota Retina Institute | Sarasota | Florida | 34239 | United States |
| Center for Retina and Macular Disease | Winter Haven | Florida | 33880 | United States |
| Southeast Retina Center, PC | Augusta | Georgia | 30909 | United States |
| Rush University Med. Ctr | Chicago | Illinois | 60612 | United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Univ. Of Kentuck/Kentucky-Clinic/Dept of Ophthal & VS | Lexington | Kentucky | 40536-0284 | United States |
| Maine Vitreoretinal Consultants, LLC, PA | Bangor | Maine | 04401 | United States |
| National Retina Institute | Towson | Maryland | 21204 | United States |
| University of Michigan-Kellogg Eye Center | Ann Arbor | Michigan | 48105 | United States |
| Kresge Eye Institute | Detroit | Michigan | 48201-1423 | United States |
| Vitreo-Retinal Associates | Grand Rapids | Michigan | 49525 | United States |
| Associated Retina Consultants | Royal Oak | Michigan | 48073 | United States |
| Vitroretinal Surgery PA | Minneapolis | Minnesota | 55435 | United States |
| Retina Vitreous Centre, PA | New Brunswick | New Jersey | 08901 | United States |
| Retina Association of NJ | Teaneck | New Jersey | 07666 | United States |
| New York Eye and Ear Infirmary | New York | New York | 10003 | United States |
| Columbia University - Harkness Eye Institute | New York | New York | 10032 | United States |
| Retina Vitreous Surgeons of Central NY | New York | New York | 13224 | United States |
| Duke Eye Center | Durham | North Carolina | 27710 | United States |
| Caroline Eye Associates | Southern Pines | North Carolina | 28387 | United States |
| Wake Forest University Eye Center | Winston-Salem | North Carolina | 27157 | United States |
| Retina Association of Cleveland | Lakewood | Ohio | 44107 | United States |
| Pennsylvania Retina Specialists, P.C. | Camp Hill | Pennsylvania | 17011 | United States |
| Allegheny Ophthalmic & Orbital Associates, PC | Pittsburgh | Pennsylvania | 15212 | United States |
| Souteastern Retina Associates | Kingsport | Tennessee | 37660 | United States |
| Austin Retina Associates | Austin | Texas | 78705 | United States |
| Vitroretinal Consultants | Houston | Texas | 77030 | United States |
| Valley Retina Institute, P.A. | McAllen | Texas | 78503 | United States |
| Retinal Consultants of San Antonio | San Antonio | Texas | 78240 | United States |
| Folgar 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. |
| 22894573 | Derived | Stalmans 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. |
| 22879421 | Derived | DeCroos 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin 125µg | 125µg microplasmin intravitreal injection |
| BG001 | Placebo | Intravitreal injection of placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Intention-To-Treat (ITT), Last Observation Carried forward (LOCF) | Posted | Number | percentage of participants | Day 28 |
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| Secondary | 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. | Intention-To-Treat (ITT, Last Observation Carried Forward (LOCF) | Posted | Number | percentage of participants | Day 28 |
|
|
Adverse Events (AEs)/Serious Adverse Events (SAEs) were collected from injection day up to 6 months post injection.
AEs/SAEs were assessed by the investigator at all study visits.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocriplasmin 125µg | 125µg ocriplasmin intravitreal injection | 32 | 220 | 127 | 220 | ||
| EG001 | Placebo | Intravitreal injection of placebo | 13 | 106 | 35 | 106 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular hole | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Retinal detachment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Small intestinal obstruction | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Upper gastrointestinal hemorrahge | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
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| Lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Pancreatic carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Pulmonary Embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Cardiac failure congestive | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Spondylolisthesis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Cerebral hemorrahge | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA 13.0 | Systematic Assessment |
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| Renal failure acute | Renal and urinary disorders | MedDRA 13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous floaters | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Conjunctival Hemorrhage | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Photopsia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Vision blurred | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Visual impairment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Photophobia | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Retinal edema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Intraocular pressure incresed | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Petra Kozma-Wiebe | ThromboGenics | +32 16751310 | petra.kozma@thrombogenics.com |
| ID | Term |
|---|---|
| C054561 | microplasmin |
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| Male |
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