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

This study has been terminated.
(Sponsor decision; not safety related)
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Lpath, Inc.
ClinicalTrials.gov Identifier:
NCT01334255
First received: April 8, 2011
Last updated: April 22, 2013
Last verified: January 2012
  Purpose

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).


Condition Intervention Phase
Pigment Epithelial Detachment
Drug: iSONEP (sonepcizumab/LT1009)
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 1b Multi-Center, Open-Label and Randomized Study of iSONEP (Sonepcizumab/LT1009) Administered as Intravitreous Injections to Subjects With PED Secondary to Exudative Age-Related Macular Degeneration or Polypoidal Choroidal Vasculopathy

Resource links provided by NLM:


Further study details as provided by Lpath, Inc.:

Primary Outcome Measures:
  • To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • To evaluate various efficacy outcomes throughout the study [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    • Changes in subretinal and intraretinal fluid, in retinal thickness and in size and height of PED compared with baseline at Days 30, 45, 60 and 90
    • Changes in CNV lesion area from baseline
    • Time course to regression of PED; proportion of subjects with complete resolution of PED following a single, second or third IVT iSONEP injection
    • Changes in VA; proportion of eyes gaining > or = 0, 5, 10 and 15 letters on ETDRS
    • Proportion of subjects with an improvement from baseline in VFQ-25 overall composite score to Day 60, Month 4 and Month 8
    • Time to re-treatment with anti-VEGF therapy

  • To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
    Production and/or changes in antibody concentration to iSONEP from baseline to the end of the study

  • To characterize the systemic pharmacokinetic profile of iSONEP [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

    For the 2.0 mg dose of iSONEP

    • Maximum plasma concentration
    • Area under the concentration versus time curve
    • Terminal half-life
    • Terminal elimination constant
    • Time of maximum concentration


Enrollment: 12
Study Start Date: March 2011
Study Completion Date: July 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 0.5 mg of iSONEP (sonepcizumab/LT1009)
iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate
Drug: iSONEP (sonepcizumab/LT1009)
Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.
Experimental: 2.0 mg of iSONEP (sonepcizumab/LT1009)
iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate
Drug: iSONEP (sonepcizumab/LT1009)
Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.

Detailed Description:

Sixteen (16) subjects per dose group who have received a minimum of 3 and no more than 7 doses of an anti-VEGF agent (i.e., Lucentis or Avastin), and whose PED has not decreased by greater than 25% in height despite therapy, will be enrolled for a total of 32 subjects. The presence of PED diagnosed by the Investigator will be confirmed by SDOCT, ICG and FA by a digital imaging reading center prior to subject enrollment. The ability of iSONEP to induce regression of persistent PED in subjects with exudative AMD or PCV despite previous treatment with an anti-VEGF agent will be evaluated.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01334255

Locations
United States, Florida
Center For Retina & Macular Disease
Winter Haven, Florida, United States, 33880
United States, Pennsylvania
Associates in Ophthalmology
West Mifflin, Pennsylvania, United States, 15122
United States, South Carolina
Palmetto Retina Center
West Columbia, South Carolina, United States, 29169
United States, Texas
Retina Research Institute of Texas
Abilene, Texas, United States, 79606
Retina Research Center
Austin, Texas, United States, 78705
Sponsors and Collaborators
Lpath, Inc.
Pfizer
Investigators
Study Chair: Glenn Stoller, MD Lpath, Inc.
  More Information

No publications provided

Responsible Party: Lpath, Inc.
ClinicalTrials.gov Identifier: NCT01334255     History of Changes
Other Study ID Numbers: LT1009-Oph-002
Study First Received: April 8, 2011
Last Updated: April 22, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Lpath, Inc.:
Pigment epithelial detachment
Exudative age-related macular degeneration
Polypoidal choroidal vasculopathy

Additional relevant MeSH terms:
Macular Degeneration
Retinal Detachment
Vascular Diseases
Wet Macular Degeneration
Cardiovascular Diseases
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on October 23, 2014