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Age-related macular degeneration (AMD) is a disease that, in time, destroys the macula, which is the central part of the retina that gives sharp central vision. The primary purpose of this study is to assess the safety of iSONEP which is a humanized monoclonal antibody against a bioactive lipid, sphingosine 1-phosphate (S1P).
S1P modulates the AMD-associated processes of angiogenesis, inflammation and fibrosis. A potential strategy for treating choroidal neovascularization associated with AMD is to reduce the biologically available extracellular levels of S1P. iSONEP is highly selective for S1P and binds with picomolar affinity. Lpath proposes that iSONEP would deprive many cell types (fibroblasts, pericytes, vascular endothelial cells and inflammatory) of important growth and survival factors thus targeting the multiple maladaptive processes of exudative AMD that ultimately result in the loss of photoreceptors, their supporting cells, and visual acuity. Targeting simultaneously multiple components of the choroidal neovascular response is a novel approach and has the potential to be more potent than "single-targeted" therapeutics such as anti-VEGF therapies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | iSONEP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iSONEP | Biological | single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye |
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine safety, tolerability, maximum tolerated dose and dose-limiting toxicity of iSONEP following a single intravitreal injection to subjects with choroidal neovascularization secondary to AMD | Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize systemic pharmacokinetics, evaluate the immunogenicity, and investigate preliminary efficacy on retinal lesion thickness determined by OCT; size and extent of CNV and lesion area; and visual acuity | Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glenn Stoller, MD | Lpath, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Retinal Consultants of Arizona, LTD | Phoenix | Arizona | 85014 | United States | ||
| Center for Retina and Macular Disease |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16530706 | Background | Visentin B, Vekich JA, Sibbald BJ, Cavalli AL, Moreno KM, Matteo RG, Garland WA, Lu Y, Yu S, Hall HS, Kundra V, Mills GB, Sabbadini RA. Validation of an anti-sphingosine-1-phosphate antibody as a potential therapeutic in reducing growth, invasion, and angiogenesis in multiple tumor lineages. Cancer Cell. 2006 Mar;9(3):225-38. doi: 10.1016/j.ccr.2006.02.023. | |
| 18723015 |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Feb 22, 2016 | |
| Reset | Mar 22, 2016 | |
| Release | Jul 1, 2016 | |
| Reset | Aug 11, 2016 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Feb 22, 2016 | Mar 22, 2016 | |||
| Jul 1, 2016 |
| ID | Term |
|---|---|
| C000619670 | sonepcizumab |
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| Winter Haven |
| Florida |
| 33880 |
| United States |
| Midwest Eye Institute | Indianapolis | Indiana | 46280 | United States |
| Vitreo-Retinal Consultants | Grand Rapids | Michigan | 49525 | United States |
| Wills Eye Institute | Philadelphia | Pennsylvania | 19107 | United States |
| Caballero S, Swaney J, Moreno K, Afzal A, Kielczewski J, Stoller G, Cavalli A, Garland W, Hansen G, Sabbadini R, Grant MB. Anti-sphingosine-1-phosphate monoclonal antibodies inhibit angiogenesis and sub-retinal fibrosis in a murine model of laser-induced choroidal neovascularization. Exp Eye Res. 2009 Mar;88(3):367-77. doi: 10.1016/j.exer.2008.07.012. Epub 2008 Aug 6. |
| Aug 11, 2016 |