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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00725686
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : October 10, 2012
Information provided by (Responsible Party):
Quark Pharmaceuticals

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

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: PF-04523655 Phase 1

Detailed Description:
Dose escalation safety study

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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").
Study Start Date : February 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Intervention Details:
  • Drug: PF-04523655
    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
    Other Name: REDD14NP

Primary Outcome Measures :
  1. To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Over a 24-Month Period ]

Secondary Outcome Measures :
  1. To describe anatomical changes in the retina and choroid following the administration of PF-04523655 [ Time Frame: Day 14 ]
  2. To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655 [ Time Frame: Day 14 ]
  3. 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 [ Time Frame: Monthly ]
  4. 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) [ Time Frame: Day 14 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00725686

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United States, California
Pfizer Investigational Site
Beverly Hills, California, United States, 90211
Pfizer Investigational Site
Pasadena, California, United States, 91105
Pfizer Investigational Site
Walnut Creek, California, United States, 94598
United States, Florida
Pfizer Investigational Site
Miami, Florida, United States, 33136
United States, Hawaii
Pfizer Investigational Site
Aiea, Hawaii, United States, 96701
United States, Maryland
Pfizer Investigational Site
Baltimore, Maryland, United States, 21205
United States, New York
Pfizer Investigational Site
New York, New York, United States, 10022
United States, Ohio
Pfizer Investigational Site
Cleveland, Ohio, United States, 44195
Pfizer Investigational Site
Petah Tikva, Israel, 49100
Pfizer Investigational Site
Rehovot, Israel, 76100
Pfizer Investigational Site
Tel Aviv, Israel, 64239
Sponsors and Collaborators
Quark Pharmaceuticals
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Study Director: Pfizer Call Center Pfizer
Additional Information:
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Responsible Party: Quark Pharmaceuticals Identifier: NCT00725686    
Obsolete Identifiers: NCT00455481
Other Study ID Numbers: B0451008
QRK.003 ( Other Identifier: Quark Pharmaceuticals Inc. )
First Posted: July 30, 2008    Key Record Dates
Last Update Posted: October 10, 2012
Last Verified: October 2012
Keywords provided by Quark Pharmaceuticals:
Choroidal Neovascularization (CNV) "WET" AMD
Additional relevant MeSH terms:
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Macular Degeneration
Choroidal Neovascularization
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Choroid Diseases
Uveal Diseases