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A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with DME.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocriplasmin 25µg | Experimental | 25µg ocriplasmin intravitreal injection versus sham injection |
|
| Ocriplasmin 75µg | Experimental | 75µg ocriplasmin intravitreal injection versus sham injection |
|
| Ocriplasmin 125µg | Experimental | 125µg ocriplasmin intravitreal injection versus sham injection |
|
| sham injection | Sham Comparator | Sham injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocriplasmin | Drug | Intravitreal injection, single administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| PVD Induction | The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT) | Day 14 post-injection |
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Inclusion Criteria include:
Exclusion Criteria include:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA OCMW Antwerpen | Antwerp | 2020 | Belgium | |||
| University Hospital of Ghent |
The trial investigated 3 doses: 25, 75 and 125µg in 3 consecutive cohorts. Patients in each cohort were to be randomized to active treatment or sham injection in a 3:1 ratio. Enrolment into the high dose microplasmin groups was to start only after acceptable safety had been achieved with the previous doses as determined by a Study Safety Committee.
The first patient was enrolled on 15 December 2006 and the last patient completed the last visit on 19 January 2010. All patients were selected in medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin 25µg | 25µg ocriplasmin intravitreal injections versus sham injection |
| FG001 | Ocriplasmin 75µg | 75µg ocriplasmin intravitreal injection versus sham injection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Sham injection | Other | Sham intravitreal injection |
|
| Ghent |
| B-9000 |
| Belgium |
| University Hospital Leuven | Leuven | Belgium |
| Ludwig Maximillian University | Munich | Germany |
| University of Milan | Milan | Italy |
| Azienda Ospedaliero-Universitaria Pisana | Pisa | Italy |
| Institute of Ophtalmology, Policlinico A: Gemelli (University Hospital),Catholic University of Sacred Heart | Rome | 00168 | Italy |
| Ospedale di Circolo di Varese, Insubria University | Varese | 21100 | Italy |
| Academic Hospital Groningen | Groningen | 9700 RB | Netherlands |
| Het Oogziekenhuis Rotterdam | Rotterdam | 3011 BH | Netherlands |
| Institut de Microcirurgia Ocular de Barcelona | Barcelona | 08022 | Spain |
| Hospital Vall D'Hebron | Barcelona | 08035 | Spain |
| Instituto Technologico de Oftalmologia SL. | Santiago de Compostela | Spain |
| Royal Liverpool & Broadgreen Hospital | Liverpool | L7 8XP | United Kingdom |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
| FG002 | 0criplasmin 125µg | 125µg ocriplasmin intravitreal injection versus sham injection |
| FG003 | Sham Injection | Sham intravitreal injection |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin 25µg | 25µg ocriplasmin intravitreal injection versus sham injection |
| BG001 | Ocriplasmin 75µg | 75µg ocriplasmin intravitreal injection versus sham injection |
| BG002 | Ocriplasmin 125µg | 125µg ocriplasmin intravitreal injection versus sham injection |
| BG003 | Sham Injection | Sham injection Sham injection : Sham intravitreal injection |
| BG004 | 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 |
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| 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 | PVD Induction | The primary efficacy variable was the proportion of patients with total posterior vitreous detachment (PVD) on Day 14 as determined by a masked central reading center (CRC) using 4-quadrant B-scan and optical coherence tomography (OCT) | Intent-To-Treat (ITT), Last Observation Carried Forward (LOCF) | Posted | Number | percentage of participants | Day 14 post-injection |
|
|
|
|
AEs/SAEs were collected from injection day up to Month 12 post-injection
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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 25µg | 25µg ocriplasmin intravitreal injection versus sham injection | 1 | 8 | 1 | 8 | ||
| EG001 | Ocriplasmin 75µg | 75µg ocriplasmin intravitreal injection versus sham injection | 4 | 15 | 4 | 15 | ||
| EG002 | Ocriplasmin 125µg | 125µg ocriplasmin intravitreal injection versus sham injection | 5 | 15 | 5 | 15 | ||
| EG003 | Sham Injection | Sham injection Sham injection : Sham intravitreal injection | 9 | 13 | 7 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| maculopathy | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infaction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Oesophageal varices haemorrhage | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Optic disc vascular disorder | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Haematoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina Pectoris | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Maculopathy | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Macular oedema | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Optic disc vascular disorder | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Retinal artery occlusion | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myocardial ischaemia | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Monoparesis | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Heamatoma | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Hypovolaemic shock | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Thrombosis | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Petra Kozma-Wiebe, MD | ThromboGenics NV | +32 16751310 | petra.kozma@thrombogenics.com |
| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C054561 | microplasmin |
| C005703 | salicylhydroxamic acid |
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| Male |
|
| Odds Ratio (OR) |
| 0.562 |
| 2-Sided |
| 95 |
| 0.132 |
| 2.400 |
| No |
| Superiority or Other |
| Fisher Exact | 0.372 | Odds Ratio (OR) | 0.346 | 95 | 0.070 | 1.703 | No | Superiority or Other |