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

NCT01334255

Last updated date
Study Location
Center For Retina & Macular Disease
Winter Haven, Florida, 33880, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pigment Epithelial Detachment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Pigment Epithelial DetachmentiSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
NCT01334255
  1. Winter Haven, Florida
  2. West Mifflin, Pennsylvania
  3. West Columbia, South Carolina
  4. Abilene, Texas
  5. Austin, Texas
ALL GENDERS
50 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
Official Title  ICMJE 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
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pigment Epithelial Detachment
Intervention  ICMJE Drug: iSONEP (sonepcizumab/LT1009)
Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.
Study Arms  ICMJE
  • Experimental: 0.5 mg of iSONEP (sonepcizumab/LT1009)
    iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate
    Intervention: Drug: iSONEP (sonepcizumab/LT1009)
  • Experimental: 2.0 mg of iSONEP (sonepcizumab/LT1009)
    iSONEP (sonepcizumab/LT1009) is a humanized murine monoclonal antibody to sphingosine 1-phosphate
    Intervention: Drug: iSONEP (sonepcizumab/LT1009)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 22, 2013)
12
Original Estimated Enrollment  ICMJE
 (submitted: April 11, 2011)
32
Actual Study Completion Date  ICMJE July 2012
Actual Primary Completion Date February 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 ?m
  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01334255
Other Study ID Numbers  ICMJE LT1009-Oph-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lpath, Inc.
Study Sponsor  ICMJE Lpath, Inc.
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Chair:Glenn Stoller, MDLpath, Inc.
PRS Account Lpath, Inc.
Verification Date January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP