Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
A Phase I Open-Label, Dose Escalation Trial Of REDD14NP Delivered By A Single Intravitreal Injection To Patients With Choroidal Neovascularization (CNV) Secondary To Exudative Age-Related Macular Degeneration ("Wet AMD").
The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
Dose escalation safety study
This is a dose-escalation study (50, 100, 200, 400, 670, 1000, 1500, 2250, 3000 microgram) given at baseline and then the subject is followed up for 24 months
Inclusion Criteria: Patient is ≥ 50 years old and in general good health. Patients with medically controlled chronic disease such as HTN, AODM, and hyperlipidemia may be included. Patient is capable of giving consent. Patient is willing and able to comply with the visit schedule and study procedures including follow-up visits. Patient has documented CNV secondary to AMD with evidence of active disease characterized by blood vessel leakage or evidence of hemorrhage. Patient has clear ocular media and adequate pupil dilation to allow good quality imaging by fundus photography. Patient's intraocular pressure is ≤ 25 mmHg Exclusion Criteria: Patient is of childbearing potential. Every female patient is considered of child-bearing potential unless she has had sterilization surgery or is post-menopausal and has not had a menstrual period for at least 12 months. Patient has CNV due to causes other than AMD, including ocular or periocular infections. Patient has lesions not easily imaged and quantified. Patient has underlying systemic disease such as cardiac, neurological, infectious disease, uncontrolled diabetes mellitis, or disease of the eye other than AMD. Patient may have medically controlled glaucoma. Patient is participating in any concurrent interventional study.