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

NCT00767949 | Unknown Phase 1

• 1 other identifier: LT1009-Oph-001
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 5

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).

Conditions

Neovascular Age Related Macular Degeneration

Keywords

wet; AMD

Outcome Measures

Primary Outcomes (1)

• 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

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

Secondary Outcomes (1)

• 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

Study Arms (1)

1

EXPERIMENTAL

iSONEP

Biological: iSONEP

Interventions

iSONEP BIOLOGICAL

single intravitreal injection of 0.2, 0.6, 1.0, 1.4 or 1.8 mg/eye

Also known as: Sonepcizumab; LT1009

1

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lpath, Inc.: lead

Study Sites (5)

Retinal Consultants of Arizona, LTD

Phoenix, Arizona, 85014, United States

Location

Center for Retina and Macular Disease

Winter Haven, Florida, 33880, United States

Location

Midwest Eye Institute

Indianapolis, Indiana, 46280, United States

Location

Vitreo-Retinal Consultants

Grand Rapids, Michigan, 49525, United States

Location

Wills Eye Institute

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Visentin B, Vekich JA, Sibbald BJ, Cavalli AL, Moreno KM, Matteo RG, Garland WA, Lu Y, Yu S, Hall HS, Kundra V, Mills GB, Sabbadini RA. Validation of an anti-sphingosine-1-phosphate antibody as a potential therapeutic in reducing growth, invasion, and angiogenesis in multiple tumor lineages. Cancer Cell. 2006 Mar;9(3):225-38. doi: 10.1016/j.ccr.2006.02.023.

  PMID: 16530706 BACKGROUND

• Caballero S, Swaney J, Moreno K, Afzal A, Kielczewski J, Stoller G, Cavalli A, Garland W, Hansen G, Sabbadini R, Grant MB. Anti-sphingosine-1-phosphate monoclonal antibodies inhibit angiogenesis and sub-retinal fibrosis in a murine model of laser-induced choroidal neovascularization. Exp Eye Res. 2009 Mar;88(3):367-77. doi: 10.1016/j.exer.2008.07.012. Epub 2008 Aug 6.

  PMID: 18723015 BACKGROUND

MeSH Terms

Interventions

sonepcizumab

Study Officials

• Glenn Stoller, MD

  Lpath, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2008
• First Posted: October 7, 2008
• Study Start: October 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: August 1, 2012
• Last Updated: April 16, 2012

Record last verified: 2012-04

Locations

US (5)