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| Name | Class |
|---|---|
| ThromboGenics | INDUSTRY |
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The purpose of this study is to determine whether microplasmin given by intravitreal injection is effective and safe for the treatment of wet age-related macular degeneration (AMD) in patients who have focal vitreomacular adhesion (VMA)
The human vitreous gel undergoes progressive liquefaction with age. Concurrent with the process of vitreous liquefaction, there is a weakening of the adhesion at the vitreoretinal interface between the cortical vitreous gel and the inner limiting lamina. Posterior vitreous detachment (PVD) is a separation of the cortical vitreous get from the inner limiting lamina. PVD is usually a sudden event during which liquefied vitreous from the center of the vitreous body bursts through a hole in the posterior vitreous cortex and then dissects the residual cortex gel away from the inner limiting lamina. If there is residual vitreoretinal traction around the break, this process may induce a tear in the retina that can in turn result in rhegmatogenous retinal detachment, macular hole, or cystoid macular edema. The importance of the vitreous in the progression of diabetic retinopathy may also extend beyond tractional considerations. For example, it is believed that the vitreous serves as scaffolding for new vessel formation and may also contribute to molecular imbalances that lead to retinopathy progression. Therefore, total PVD, by releasing vitreoretinal traction as well as other potential mechanisms, may be beneficial in various vitreoretinal diseases such as neovascular AMD.
Vitreomacular adhesion (VMA) in exudative (wet) AMD may be associated with poor prognosis in patients with AMD. This trial is primarily aimed at showing that release of VMA can be induced by microplasmin, a proteolytic enzyme, in patients with wet AMD, and that microplasmin is safe in patients w/ neovascular (wet) AMD. Secondary endpoint will be assessment of improved AMD outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| microplasmin, intravitreal injection | Experimental | Subjects will receive one intravitreal injection of microplasmin on Day 0. |
|
| Placebo | Placebo Comparator | Subjects will receive one intravitreal injection of the placebo on Day 0. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microplasmin | Drug | Microplasmin, 1.875 mg, will be given by intravitreal injection,on Day 0. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome is the proportion of patients in whom there is release of vitreomacular traction as assessed by ultrasonography, optical coherence tomography and physical examination | Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Total number of ranibizumab injections following microplasmin in those with PVD compared with those without PVD | 12 months | |
| Change in mean macular thickness | Day 28 and month 12 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rosaleen M Ostrick, MPH, MA | Contact | 310-794-5595 | ostrick@jsei.ucla.edu | |
| Logan Hitchcock, B.S. | Contact | 310-794-5596 | hitchcock@jsei.ucla.edu |
| Name | Affiliation | Role |
|---|---|---|
| Steven D Schwartz, M.D. | University of California, Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jules Stein Eye Institute/UCLA | Recruiting | Los Angeles | California | 90095 | United States |
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| 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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| Placebo control | Drug | The placebo control will be the microplasmin vehicle without the microplasmin. |
|
| Mean change in ETDRS visual acuity |
| Day 28 and Month 12 |
| Incidence and severity of ocular adverse events | Day 28 and Month 12 |
| Incidence and severity of nonocular adverse events | Day 28 and Month 12 |