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

• Status: Terminated
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lpath, Inc.
• Collaborator: Pfizer

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