Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)

• Status: Completed
• Trial end date: 2010-11-01
• Target enrollment: 0
• Participant gender: All

Summary

The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD

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

Details

• Lead Sponsor: Quark Pharmaceuticals
• Collaborator: Pfizer

Criteria

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.