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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye
Retinal Consultants of Arizona, LTD
Phoenix, Arizona, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Vitreo-Retinal Consultants
Grand Rapids, Michigan, United States
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
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Wills Eye Institute
Philadelphia, Pennsylvania, United States