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

• To evaluate safety and tolerability following one, two or three intravitreous injections of iSONEP [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  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.
  
  

• To evaluate various efficacy outcomes throughout the study [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  • 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
  
  
• To evaluate the immunogenicity (antibody response) of iSONEP following multiple intravitreous injections [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]
  Production and/or changes in antibody concentration to iSONEP from baseline to the end of the study
  
  
• To characterize the systemic pharmacokinetic profile of iSONEP [ Time Frame: 8 months ] [ Designated as safety issue: Yes ]

  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
  
  

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.