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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin 125µg | Experimental | 125µg of ocriplasmin intravitreal injection |
|
| Placebo | Placebo Comparator | Intravitreal injection of placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocriplasmin 125µg | Drug | 125µg of ocriplasmin intravitreal injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Diagnostic Center | Campbell | California | 95008 | United States | ||
| West Coast Retina Group, Inc |
| 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 23 Dec 2008 and last patient completed the study on 15 Jun 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 | Intravitreal injection placebo. |
|
| San Francisco |
| California |
| 94107 |
| United States |
| California Retina Consultants | Santa Barbara | California | 93103 | United States |
| Medeye | Miami | Florida | 33143 | United States |
| Retina Specialists | Pensacola | Florida | 32503 | United States |
| Paducah Retinal Center | Paducah | Kentucky | 42001 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Vision Research Center at Truman Medical Center | Kansas City | Missouri | 64108 | United States |
| Deleware Valley Retina Associates | Lawrenceville | New Jersey | 08648 | United States |
| Capital Region Retina | Albany | New York | 12206 | United States |
| Southeast Clinical Research Assoicates, PA | Charlotte | North Carolina | 28210 | United States |
| Dean A McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | United States |
| Scheie Eye Institute, Penn Eye Care | Philadelphia | Pennsylvania | 19104 | United States |
| Black Hils regional Eye Institute | Rapid City | South Dakota | 57701 | United States |
| Texas Retina Associates | Arlington | Texas | 76012 | United States |
| Retina Research Center | Austin | Texas | 78705 | United States |
| Retina Consultants | Fort Worth | Texas | 76104 | United States |
| Medical Center Ophthalmology Assoc. | San Antonio | Texas | 78240 | United States |
| Eye Care Associates | Tyler | Texas | 75701 | United States |
| Vitreoretinal Associates | Seattle | Washington | 98104 | United States |
| University Hospital Leuven | Leuven | Belgium |
| University Hospital Brno | Brno | 625 00 | Czechia |
| University Hospital Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| University Hospital Olomouc | Olomouc | 775 20 | Czechia |
| University Hospital Kralovske Vinohrady | Prague | 100 34 | Czechia |
| Central Military Hospital | Prague | 169 02 | Czechia |
| Gemini Eye Clinic | ZlÃn | 760 01 | Czechia |
| Augenklinik-Universität Bonn | Bonn | D-53127 | Germany |
| St. Joseph Stift Bremen Abteilung für Augenheilkunde | Bremen | 28209 | Germany |
| Universitäts-Augenklinik Frankfurt am Main | Frankfurt | 60590 | Germany |
| Städtische Kliniken Frankfurt am Main, Klinik für Augenheilkunde | Frankfurt am Main | 65929 | Germany |
| Universität Göttingen | Göttingen | 37075 | Germany |
| Klinik und Poliklinik für Augenheilkunde | Leipzig | 04103 | Germany |
| Philipps Universität Marburg | Marburg | 35037 | Germany |
| Augenklinik der Ludwig Maximilians Universität München | München | 80336 | Germany |
| Augenärzte am St. Franziskus Hospital | Münster | 48145 | Germany |
| Augenklinik im Dietrich- | Neubrandenburg | 17036 | Germany |
| Indywidualna Specjalistyczna Praktyka Prywatna | Gdansk | 80-147 | Poland |
| Oddział Okulistyczny OSK, | Katowice | 40-760 | Poland |
| Instituto OftalmologÃa de Alicante (Vissum) | Alicante | 03016 | Spain |
| Centro Teknon-Institut de la Macula i de la Retina | Barcelona | 08022 | Spain |
| Hospital La Paz | Madrid | 28046 | Spain |
| Instituto Technologico de Oftalmologia S.L | Santiago de Compostela | 15705 | Spain |
| Hospital General de Valencia | Valencia | 46014 | Spain |
| St Paul's Eye Unit | Liverpool | L7 8XP | United Kingdom |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| Southampton Eye Unit, Southampton General Hospital | Southampton | SO16 6YD | United Kingdom |
| Wolverhampton Eye Infirmary-New Cross Hospital | Wolverhampton | WV10 0QP | United Kingdom |
| 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. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin 125µg | 125µg ocriplasmin intravitreal injection. |
| BG001 | Placebo | Intravitreal injection of placebo |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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. | 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 | Proportion of subjects with total 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 after 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 125ug | 125ug ocriplasmin intravitreal injection | 33 | 245 | 105 | 245 | ||
| EG001 | Placebo | Intravitreal injection of placebo | 11 | 81 | 22 | 81 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular hole | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vitreous adhesions | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Visual acuity reduced | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Eye inflammation | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Hyphaema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Posterior capsule opacification | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Retinal detachment | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Vitreous haemorrhage | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Joint dislocation | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Rib fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Spinal fracture | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
| |
| Upper limb fracture | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Wrist fracture | Eye disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Presyncope | Nervous system disorders | MedDRA 13.0 | Systematic Assessment |
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| Transient ischaemic attack | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Angina unstable | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Arteriosclerosis coronay artery | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Atrial fibrilation | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Sick sinus syndrome | Cardiac disorders | MedDRA 13.0 | Systematic Assessment |
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| Brain cancer metastatic | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 13.0 | Systematic Assessment |
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| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | 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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| Gastrointestinal haemorrahge | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Penumonia | Infections and infestations | MedDRA 13.0 | Systematic Assessment |
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| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Reumathoid arthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 | Systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 13.0 | Systematic Assessment |
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| Depression | 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 |
| |
| Conjuctival haemorrahge | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Eye pain | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Photopsia | 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 acuity reduced | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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| Macular oedema | Eye disorders | MedDRA 13.0 | Systematic Assessment |
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Varying agreements. The most restrictive is as follows: The Centre and Investigator agree to neither publish nor make public any of the results of the Study without the prior written consent from Sponsor, which consent shall not be unreasonably withheld.
| 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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