Status:
COMPLETED
Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
Lead Sponsor:
Quark Pharmaceuticals
Collaborating Sponsors:
Pfizer
Conditions:
Age-Related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE1
Brief Summary
The aim of the study is to evaluate whether PF-04523655 is safe in the treatment of neovascular/wet AMD
Detailed Description
Dose escalation safety study
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2010
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00725686
Start Date
February 1 2007
End Date
November 1 2010
Last Update
October 10 2012
Active Locations (11)
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1
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
2
Pfizer Investigational Site
Pasadena, California, United States, 91105
3
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
4
Pfizer Investigational Site
Miami, Florida, United States, 33136