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| ID | Type | Description | Link |
|---|---|---|---|
| MIVI-IIT |
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A multicenter study to compare multiple doses of intravitreal microplasmin for non-surgical PVD induction for treatment of patients with vitreomacular traction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ocriplasmin 75µg single injection | Experimental | Ocriplasmin 75µg single injection versus sham injection |
|
| ocriplasmin 125µg single injection | Experimental | Ocriplasmin 125µg single injection versus sham injection |
|
| ocriplasmin 175µg single injection | Experimental | Ocriplasmin 175µg single injection versus sham injection |
|
| ocriplasmin 125µg multiple injections | Experimental | Ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125µg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125µg. |
|
| sham injection | Sham Comparator | sham injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ocriplasmin | Drug | Intravitreal injection of ocriplasmin solution containing 75µg of ocriplasmin. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | Day 14 |
| Measure | Description | Time Frame |
|---|---|---|
| Resolution of Vitreomacular Traction (Investigator's Assessment) | Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ZNA OCMW Antwerpen | Antwerp | 2020 | Belgium | |||
| University Hospital of Ghent |
All subjects in all cohorts had a similar follow-up schedule to the day 28 post-injection visit. After day 28, non-responders in cohort 4 received up to 2 repeated injections and thus had a different study follow-up schedule than all other subjects.
The first patient was enrolled on 2 March 2007 and the last patient completed the last visit on 8 January 2009. All patients were selected in medical clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocriplasmin 75µg Single Injection | Ocriplasmin 75µg single injection versus sham injection |
| FG001 | Ocriplasmin 125µg Single Injection | ocriplasmin 125µg single injection versus sham injection |
| FG002 | Ocriplasmin 175µg Single Injection | ocriplasmin 175µg single injection versus sham injection |
| FG003 | Ocriplasmin 125µg Multiple Injections | ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg. |
| FG004 | Sham Injection | sham injection |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ocriplasmin 75µg Single Injection | ocriplasmin 75µg single injection versus sham injection |
| BG001 | Ocriplasmin 125µg Single Injection | ocriplasmin 125µg single injection versus sham injection |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Resolution of Vitreomacular Traction (Investigator's Assessment) | Resolution of VMT was evaluated by the investigator using optical coherence tomography (OCT).Resolution of VMT was defined as a change from baseline status of Yes to post-injection status of No and was evaluated by the investigator using OCT. Subjects undergoing vitrectomy had their last observation prior to vitrectomy carried forward. | Intention to Treat (ITT) | Posted | Number | Percentage of participants | Day 28 |
|
AEs/SAEs were collected from injection day up to 6 months after 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 75µg | Ocriplasmin 75µg single injection versus sham injection |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal vein occlusion | Eye disorders | MedDRA 10.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vitreous floaters | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Petra Kozma-Wiebe, MD | ThromboGenics | +32 16751310 | petra.kozma@thrombogenics.com |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C054561 | microplasmin |
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|
| ocriplasmin | Drug | Intravitreal injection of ocriplasmin solution containing 125µg of ocriplasmin with up to 2 additional (open label) 125µg ocriplasmin injection at 1 month interval. |
|
|
| Sham Comparator | Drug | Intravitreal sham injection |
|
|
| Day 28 |
| Ghent |
| B-9000 |
| Belgium |
| Universitaire Ziekenhuizen K.U.Leuven | Leuven | Belgium |
| Augenklinik der Universitat Munchen | München | 80336 | Germany |
| BG002 | Ocriplasmin 175µg Single Injection | ocriplasmin 175µg single injection versus sham injection |
| BG003 | Ocriplasmin 125µg Multiple Injections | ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg. |
| BG004 | Sham Injection | sham injection |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Ocriplasmin 175µg single injection versus sham injection
| OG002 | Ocriplasmin 125µg Pooled | Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection |
| OG003 | Sham Injection | sham injection |
|
|
|
| Primary | Proportion of Subjects With Total PVD at the First Day 14 Post-injection Visit (Vitreous Detachment to the Equator) as Determined by Masked Central Reading Center (CRC) Evaluation of B-scan Imaging. | Intention to Treat (ITT) | Posted | Number | percentage of participants | Day 14 |
|
|
|
|
| 3 |
| 12 |
| 10 |
| 12 |
| EG001 | Ocriplasmin 125µg Single Injection | Ocriplasmin 125µg single injection versus sham injection | 2 | 13 | 10 | 13 |
| EG002 | Ocriplasmin 175µg Single Injection | Ocriplasmin 175µg single injection versus sham injection | 3 | 11 | 10 | 11 |
| EG003 | Ocriplasmin 125µg Multiple Injection | Ocriplasmin 125µg multiple injection versus sham injection | 4 | 12 | 11 | 12 |
| EG004 | Sham Injection | Sham injection | 0 | 12 | 9 | 12 |
| Macular hole | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Silent Myocardial infarction | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
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| Arteriosclerosis | Vascular disorders | MedDRA 10.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Hyperthyroidism | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
|
| Colon cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 10.1 | Systematic Assessment |
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| Vitritis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Macular hole | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Conjuctival hyperaemia | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anterior chamber flare | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Conjunctival haemorrhage | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Eyelid oedema | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Macular oedema | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Macular pseudohole | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Retinal haemorrhage | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Anterior chamber cell | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Keratitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Macular scar | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Maculopathy | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Meibomianitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Optic nerve cupping | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Papilloedema | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Vitreous opacities | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Blepharitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Iridocyclitis | Eye disorders | MedDRA 10.1 | Systematic Assessment |
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| Ocular hyperaemia | Eye disorders | MedDRA 10.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Herpes zoster | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Rhinitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Fungal skin infection | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
|
| Tracheitis | Infections and infestations | MedDRA 10.1 | Systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA 10.1 | Systematic Assessment |
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| Abdominal rigidity | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Oesophageal stenosis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Reflux oesophagitis | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 10.1 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Syncope | Nervous system disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypersensitivity | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Systemic lupus erythematosus | Immune system disorders | MedDRA 10.1 | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Ostheoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 10.1 | Systematic Assessment |
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| Hypoglycaemia | Endocrine disorders | MedDRA 10.1 | Systematic Assessment |
|
| Periorbital haematoma | Injury, poisoning and procedural complications | MedDRA 10.1 | Systematic Assessment |
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| Depression | Psychiatric disorders | MedDRA 10.1 | Systematic Assessment |
|
| Psoriasis | Skin and subcutaneous tissue disorders | MedDRA 10.1 | Systematic Assessment |
|
| Platelet count decreased | Investigations | MedDRA 10.1 | Systematic Assessment |
|
| Dyspnoea | Cardiac disorders | MedDRA 10.1 | Systematic Assessment |
|
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| No |
| Superiority or Other |
| Fisher Exact | 0.5343 | No | Superiority or Other |