A Phase 1 interventional study of iSONEP in Neovascular Age Related Macular Degeneration, sponsored by Lpath, Inc.. Status unknown at 5 sites in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-04-16.
Sponsored by Lpath, Inc. · Phase 1, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 15 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Lpath, Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
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Exclusion Criteria:
iSONEP
Biological: iSONEP
single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye
Also known as: Sonepcizumab; LT1009
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
Time frame: Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection
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
Time frame: Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection
This study is status unknown, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Lpath, Inc.