A Phase 1, Dose-Escalating, Multi-Center, Study of iSONEP (Sonepcizumab [LT1009]) Administered as an Intravitreal Injection to Subjects With Choroidal Neovascularization Secondary to Age-Related Macular Degeneration
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Neovascular Age Related Macular Degeneration
- Sponsor
- Lpath, Inc.
- Enrollment
- 15
- Locations
- 5
- Primary Endpoint
- 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
- Last Updated
- 14 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •50 years and older
- •BCVA ETDRS letter score in study eye between 20-57 letters using ETDRS refraction (Snellen of 20/70-20/400)
- •Any CNV secondary to AMD in study eye, classic, minimally classic or occult with leakage on fluorescein angiography and intraretinal or subretinal fluid on OCT
- •Visual acuity in fellow eye must be 20/800 or better at 4 meters
- •Able to read, understand and sign the consent form before entering into study
Exclusion Criteria
- •Ocular disease other than CNV that could compromise vision in study eye
- •Systemic immunosuppressive medication/therapy (e.g., chemotherapy, steroids)
- •Uncontrolled hypertension and/or arrhythmias
- •QT/QTc interval measurement \>450 msec
- •Cancer within the last 2 years except superficial basal or squamous cell skin cancer or cervical carcinoma in situ
- •Have angioid streaks, presumed ocular histoplasmosis syndrome, myopia (\>8 diopters) or CNV secondary to other causes than AMD
- •Any additional ocular diseases which have irreversibly compromised visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy, clinically significant diabetic macular edema and severe non-proliferative diabetic retinopathy
- •Any intraocular or general surgery, including cataract surgery, within 2 months of Day 1
- •History of uveitis in either eye
- •Any ocular or periocular infection within 4 weeks prior to Day 1
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)