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

Phase 1TerminatedNCT01334255

Lpath, Inc.12 enrolled

Overview

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).

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pigment Epithelial Detachment

Interventions

iSONEP (sonepcizumab/LT1009)DRUG

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

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (5)

Center For Retina & Macular Disease

Winter Haven, Florida, United States

Associates in Ophthalmology

West Mifflin, Pennsylvania, United States

Palmetto Retina Center

West Columbia, South Carolina, United States

Retina Research Institute of Texas

Abilene, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 8 months

Secondary Outcomes

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

Time frame: 8 months

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

Time frame: 8 months

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

Time frame: 8 months

Data from ClinicalTrials.gov

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