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

Pigment Epithelial Detachment Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01334255
• Other study ID #: LT1009-Oph-002
• Status: Terminated
• Phase: Phase 1
• First received: April 8, 2011
• Last updated: April 22, 2013
• Start date: March 2011
• Est. completion date: July 2012

Study information

• Verified date: January 2012
• Source: Lpath, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: July 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Pigment Epithelial Detachment
• Retinal Detachment
• Vascular Diseases
• Wet Macular Degeneration

Intervention

Drug:
• iSONEP (sonepcizumab/LT1009)
Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.

Locations

Country	Name	City	State
United States	Retina Research Institute of Texas	Abilene	Texas
United States	Retina Research Center	Austin	Texas
United States	Palmetto Retina Center	West Columbia	South Carolina
United States	Associates in Ophthalmology	West Mifflin	Pennsylvania
United States	Center For Retina & Macular Disease	Winter Haven	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Lpath, Inc.	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	8 months	Yes
Secondary	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	8 months	Yes
Secondary	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	8 months	Yes