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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lpath, Inc.
ClinicalTrials.gov Identifier:
NCT00767949
First received: October 2, 2008
Last updated: April 13, 2012
Last verified: April 2012
History of Changes
  Purpose

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).


Condition Intervention Phase
Neovascular Age Related Macular Degeneration
 Biological: iSONEP
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lpath, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: October 2008
Estimated Study Completion Date: August 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
iSONEP
 Biological: iSONEP
single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye
Other Name: Sonepcizumab; LT1009

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00767949

Locations
United States, Arizona
Retinal Consultants of Arizona, LTD
Phoenix, Arizona, United States, 85014
United States, Florida
Center for Retina and Macular Disease
Winter Haven, Florida, United States, 33880
United States, Indiana
Midwest Eye Institute
Indianapolis, Indiana, United States, 46280
United States, Michigan
Vitreo-Retinal Consultants
Grand Rapids, Michigan, United States, 49525
United States, Pennsylvania
Wills Eye Institute
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Lpath, Inc.
Investigators
Study Director: Glenn Stoller, MD Lpath, Inc.
  More Information

Publications:

Responsible Party: Lpath, Inc.
ClinicalTrials.gov Identifier: NCT00767949     History of Changes
Other Study ID Numbers: LT1009-Oph-001
Study First Received: October 2, 2008
Last Updated: April 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Lpath, Inc.:
wet
AMD

Additional relevant MeSH terms:
Macular Degeneration
Wet Macular Degeneration
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases
Eye Diseases
 Choroid Diseases
Uveal Diseases
Neovascularization, Pathologic
Metaplasia
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013