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

Lpath

Status and phase: Terminated; Phase 1

Conditions: Pigment Epithelial Detachment

Treatments: Drug: iSONEP (sonepcizumab/LT1009)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01334255

LT1009-Oph-002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 50+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

0.5 mg of iSONEP (sonepcizumab/LT1009)

Experimental group

Description:

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

Treatment:

Drug: iSONEP (sonepcizumab/LT1009)

2.0 mg of iSONEP (sonepcizumab/LT1009)

Experimental group

Description:

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

Treatment:

Drug: iSONEP (sonepcizumab/LT1009)