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

Quark Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Age-Related Macular Degeneration

Treatments

Drug: PF-04523655

Study type

Interventional

Funder types

Industry

Identifiers

B0451008

QRK.003 (Other Identifier)

Details and patient eligibility

About

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

Full description

Dose escalation safety study

Enrollment

54 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.