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

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Drug: PF-04523655

Detailed Description

Dose escalation safety study

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Phase 1

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel, 49100
    • Pfizer Investigational Site
  • Rehovot, Israel, 76100
    • Pfizer Investigational Site
  • Tel Aviv, Israel, 64239
    • Pfizer Investigational Site
• United States
  • California
    • Beverly Hills, California, United States, 90211
      • Pfizer Investigational Site
    • Pasadena, California, United States, 91105
      • Pfizer Investigational Site
    • Walnut Creek, California, United States, 94598
      • Pfizer Investigational Site
  • Florida
    • Miami, Florida, United States, 33136
      • Pfizer Investigational Site
  • Hawaii
    • Aiea, Hawaii, United States, 96701
      • Pfizer Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Pfizer Investigational Site
  • New York
    • New York, New York, United States, 10022
      • Pfizer Investigational Site
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Pfizer Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection	Over a 24-Month Period

Secondary Outcome Measures

Outcome Measure	Time Frame
To describe anatomical changes in the retina and choroid following the administration of PF-04523655	Day 14
To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655	Day 14
To evaluate the safety, efficacy and frequency of dosing following administration of PF-04523655 of approved VEGF-inhibitors in those study patients requiring rescue therapy	Monthly
To evaluate early response after a single intravitreal administration of PF-04523655 in patients who, in the opinion of the investigator, have the potential to show improvement in visual acuity from other treatment options (Stratum 2 patients)	Day 14

Collaborators and Investigators

• Sponsor: Quark Pharmaceuticals
• Collaborators: Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start: February 1, 2007
• Primary Completion (Actual): November 1, 2010
• Study Completion (Actual): November 1, 2010

Study Registration Dates

• First Submitted: July 28, 2008
• First Submitted That Met QC Criteria: July 28, 2008
• First Posted (Estimate): July 30, 2008

Study Record Updates

• Last Update Posted (Estimate): October 10, 2012
• Last Update Submitted That Met QC Criteria: October 5, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: Choroidal Neovascularization (CNV) "WET" AMD
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Degeneration; Retinal Diseases; Uveal Diseases; Choroid Diseases; Metaplasia; Macular Degeneration; Choroidal Neovascularization; Neovascularization, Pathologic
• Other Study ID Numbers: B0451008; QRK.003 (Other Identifier: Quark Pharmaceuticals Inc.)