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

Pigment Epithelial Detachment Clinical Trial

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

Status Terminated

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).

Clinical Trial 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 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

• NCT number: NCT01334255
• Study type: Interventional
• Source: Lpath, Inc.
• Status: Terminated
• Phase: Phase 1
• Start date: March 2011
• Completion date: July 2012