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

Primary Purpose

Pigment Epithelial Detachment

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

iSONEP (sonepcizumab/LT1009)

About this trial

This is an interventional treatment trial for Pigment Epithelial Detachment focused on measuring Pigment epithelial detachment, Exudative age-related macular degeneration, Polypoidal choroidal vasculopathy

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center For Retina & Macular Disease
Associates in Ophthalmology
Palmetto Retina Center
Retina Research Institute of Texas
Retina Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

0.5 mg of iSONEP (sonepcizumab/LT1009)

2.0 mg of iSONEP (sonepcizumab/LT1009)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

To evaluate various efficacy outcomes throughout the study

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

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

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

Full Information

NCT ID

NCT01334255

First Posted

April 8, 2011

Last Updated

April 22, 2013

Sponsor

Lpath, Inc.

Collaborators

Pfizer

1. Study Identification

Unique Protocol Identification Number

NCT01334255

Brief Title

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

Acronym

PED

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Terminated

Why Stopped

Sponsor decision; not safety related

Study Start Date

March 2011 (undefined)

Primary Completion Date

February 2012 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lpath, Inc.

Collaborators

Pfizer

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pigment Epithelial Detachment

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

0.5 mg of iSONEP (sonepcizumab/LT1009)

Arm Type

Experimental

Arm Description

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

Arm Title

2.0 mg of iSONEP (sonepcizumab/LT1009)

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

iSONEP (sonepcizumab/LT1009)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

8 months

Secondary Outcome Measure Information:

Title

To evaluate various efficacy outcomes throughout the study

Description

Time Frame

8 months

Title

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

Description

Production and/or changes in antibody concentration to iSONEP from baseline to the end of the study

Time Frame

8 months

Title

To characterize the systemic pharmacokinetic profile of iSONEP

Description

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

Time Frame

8 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Glenn Stoller, MD

Organizational Affiliation

Lpath, Inc.

Official's Role

Study Chair

Facility Information:

Facility Name

Center For Retina & Macular Disease

City

Winter Haven

State/Province

Florida

ZIP/Postal Code

33880

Country

United States

Facility Name

Associates in Ophthalmology

City

West Mifflin

State/Province

Pennsylvania

ZIP/Postal Code

15122

Country

United States

Facility Name

Palmetto Retina Center

City

West Columbia

State/Province

South Carolina

ZIP/Postal Code

29169

Country

United States

Facility Name

Retina Research Institute of Texas

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

Retina Research Center

City

Austin

State/Province

Texas

ZIP/Postal Code

78705

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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