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The purpose of this trial is to evaluate the safety and preliminary efficacy of different doses and several exposure times of intravitreal microplasmin in the setting of pars plana vitrectomy for vitreomacular traction maculopathy.
Study drug will be administered in the mid-vitreous by injection. Patients will be enrolled into the cohorts in a sequential dose/time-escalating fashion. To ensure that enrolment is evenly balanced across eligible conditions, enrolment of any specific underlying disease type into any cohort will be capped at five (5) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
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| 2 | Experimental |
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| 3 | Experimental |
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| 4 | Experimental |
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| 5 | Experimental |
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| 6 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microplasmin | Drug | 25ug injected 1 hr prior to PPV, 24 hr and 7 days prior to PPV, 50ug injected 24 hr prior to PPV, 75ug injected 24 hr prior to PPV and 125ug injected 24 hr prior to PPV. |
| Measure | Description | Time Frame |
|---|---|---|
| Grade of Posterior Vitreous Detachment (PVD) preoperatively and release of vitreomacular traction | Baseline, 1,2 and 3hr, 1, 3, 14, 28, 90 and 180 Days |
| Measure | Description | Time Frame |
|---|---|---|
| The occurrence of any (serious) adverse event | Throught-out the study |
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Inclusion Criteria:
Patients with vitreomacular traction maculopathy for whom vitrectomy is indicated, according to the principal investigator, including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc deSmet, Prof. Dr | Amsterdam UMC, location VUmc | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Gasthuisberg | Leuven | B-3000 | Belgium | |||
| Academic Medical Center, University of Amsterdam |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
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| ID | Term |
|---|---|
| C054561 | microplasmin |
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| Amsterdam |
| 1105 AZ |
| Netherlands |
| Oogziekenhuis Rotterdam | Rotterdam | 3011 BH | Netherlands |