This trial is active, not recruiting.

Condition neovascular age related macular degeneration
Treatment isonep
Phase phase 1
Sponsor Lpath, Inc.
Start date October 2008
End date July 2010
Trial size 15 participants
Trial identifier NCT00767949, LT1009-Oph-001


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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
isonep Sonepcizumab; LT1009
single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye

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
time frame: Active phase: 30 days post-injection; Follow-up phase: 12 months post-injection

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title 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
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.
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Lpath, Inc..