iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)

NCT01334255 | Terminated Phase 1

• 1 other identifier: LT1009-Oph-002
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 5

Brief Summary

LT1009-Oph-002 is a Phase 1b study designed to evaluate the safety and potential efficacy of iSONEP following one, two or three injections of iSONEP, as needed, for the treatment of Pigment Epithelial Detachment (PED) secondary to PED Secondary to Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV).

Conditions

Pigment Epithelial Detachment

Keywords

Pigment epithelial detachment; Exudative age-related macular degeneration; Polypoidal choroidal vasculopathy

Outcome Measures

Primary Outcomes (1)

• To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP

  The number of participants with adverse events; changes in electrocardiogram parameters, diastolic and systolic blood pressure, pulse, temperature and intraocular pressure from baseline to the end of the study.

  8 months

Secondary Outcomes (3)

• To evaluate various efficacy outcomes throughout the study

  8 months

• To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections

  8 months

• To characterize the systemic pharmacokinetic profile of iSONEP

  8 months

Study Arms (2)

0.5 mg of iSONEP (sonepcizumab/LT1009)

EXPERIMENTAL

iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate

Drug: iSONEP (sonepcizumab/LT1009)

2.0 mg of iSONEP (sonepcizumab/LT1009)

EXPERIMENTAL

iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate

Drug: iSONEP (sonepcizumab/LT1009)

Interventions

iSONEP (sonepcizumab/LT1009) DRUG

Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.

0.5 mg of iSONEP (sonepcizumab/LT1009); 2.0 mg of iSONEP (sonepcizumab/LT1009)

Eligibility Criteria

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

You may qualify if:

• Males and females \> 50 years of age with a diagnosis of PED secondary to AMD or PCV
• Serous and/or fibrovascular PED secondary to exudative AMD or secondary to PCV (confirmed by SDOCT, FA and ICG) that has not demonstrated at least a 25% decrease in the height of the PED (from the onset of anti-VEGF therapy) following a minimum of 3 doses of an anti-VEGF agent (i.e., Lucentis or Avastin)
• PED that has a height greater than 100 μm
• Presence of CNV secondary to (i) AMD (based on FA) or (ii) PCV (based on ICG)
• ETDRS BCVA of 20/32 to 20/320 (letter score of 73 to 25) in the study eye
• ETDRS visual acuity of 20/400 or better in the fellow eye

You may not qualify if:

• Subjects previously treated with, or are currently receiving treatment with another investigational agent or device for neovascular AMD in the study eye
• Subjects who have received \< 3 and \> 7 anti-VEGF treatments in the study eye
• Subjects with retinal angiomatous proliferation (RAP lesion)
• Lucentis or Avastin within 30 days prior to Day 1 in the study eye

Sponsors & Collaborators

• Lpath, Inc.: lead
• Pfizer: collaborator

Study Sites (5)

Center For Retina & Macular Disease

Winter Haven, Florida, 33880, United States

Location

Associates in Ophthalmology

West Mifflin, Pennsylvania, 15122, United States

Location

Palmetto Retina Center

West Columbia, South Carolina, 29169, United States

Location

Retina Research Institute of Texas

Abilene, Texas, 79606, United States

Location

Retina Research Center

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Retinal Detachment; Polypoidal Choroidal Vasculopathy

Interventions

sonepcizumab

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Choroidal Neovascularization; Choroid Diseases; Uveal Diseases; Neovascularization, Pathologic; Metaplasia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Glenn Stoller, MD

  Lpath, Inc.

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: April 8, 2011
• First Posted: April 13, 2011
• Study Start: March 1, 2011
• Primary Completion: February 1, 2012
• Study Completion: July 1, 2012
• Last Updated: April 23, 2013

Record last verified: 2012-01

Locations

US (5)