Clinical trial NCT01334255: iSONEP to Treat Persistent Pigment Epithelial Detachment (PED) in Subjects With Exudative Age-Related Macular Degeneration (AMD) or Polypoidal Choroidal Vasculopathy (PCV)
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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pigment Epithelial Detachment
Keywords: Pigment epithelial detachment
Exudative age-related macular degeneration
Polypoidal choroidal vasculopathy
Lead sponsor: Lpath, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2011-04-13
Enrollment: 12
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP
timeFrame: 8 months
Secondary outcomes:
measure: To evaluate various efficacy outcomes throughout the study
timeFrame: 8 months
measure: To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections
timeFrame: 8 months
measure: To characterize the systemic pharmacokinetic profile of iSONEP
timeFrame: 8 months
Other outcomes:
Locations:
city: Winter Haven
country: United States
facility: Center For Retina & Macular Disease
state: Florida
city: West Mifflin
country: United States
facility: Associates in Ophthalmology
state: Pennsylvania
city: West Columbia
country: United States
facility: Palmetto Retina Center
state: South Carolina
city: Abilene
country: United States
facility: Retina Research Institute of Texas
state: Texas
city: Austin
country: United States
facility: Retina Research Center
state: Texas
Study officials:
affiliation: Lpath, Inc.
name: Glenn Stoller, MD
role: STUDY_CHAIR
References: