Safety Study of iSONEP (Sonepcizumab/LT1009) to Treat Neovascular Age-related Macular Degeneration

Lpath

Status and phase

Unknown

Phase 1

Conditions

Neovascular Age Related Macular Degeneration

Treatments

Biological: iSONEP

Study type

Interventional

Funder types

Industry

Identifiers

NCT00767949

LT1009-Oph-001

Details and patient eligibility

About

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).

Full 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.

Enrollment

15 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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
Active ocular inflammation grade trace and above
Cup to disc ratio >0.8, IOP >21 mmHg in glaucoma subjects treated with more than 2 ocular hypotensive agents
Previous pars plana vitrectomy or trabeculectomy in study eye
History of anterior vitrectomy
Inability to obtain photographs, FA or OCT to document CNV, e.g. due to media opacity, allergy to fluorescein dye or lack of venous access
Aphakia
Previous intravitreal Macugen, Avastin or Lucentis (injection or drug device implantation) in study eye within 6 weeks or triamcinolone within 6 months
Receiving or requiring chronic concomitant therapy with systemic anti-angiogenic treatments p.o., parenteral (excluding inhaled steroids) (>5 mg) or topical corticosteroids in the study eye
PDT within 12 weeks prior to Day 1
Subjects taking systemic anticoagulants such as warfarin
Investigational agents or devices within 6 weeks prior to Day 1
Females who are pregnant or nursing and women of child bearing potential who are not using adequate contraceptive precautions