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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.
 
ClinicalTrials.gov Identifier: NCT00725686
Recruitment Status : Completed
First Posted : July 30, 2008
Last Update Posted : October 10, 2012
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE July 28, 2008
First Posted Date  ICMJE July 30, 2008
Last Update Posted Date October 10, 2012
Study Start Date  ICMJE February 2007
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 12, 2009)
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Over a 24-Month Period ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Monthly ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 28, 2008)
  • To describe anatomical changes in the retina and choroid following the administration of PF-04523655 [ Time Frame: Day 14 ]
  • To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: Day 14 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
Official Title  ICMJE 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").
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-Related Macular Degeneration
Intervention  ICMJE 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
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 12, 2009)
54
Original Estimated Enrollment  ICMJE
 (submitted: July 28, 2008)
27
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00725686
Other Study ID Numbers  ICMJE B0451008
QRK.003 ( Other Identifier: Quark Pharmaceuticals Inc. )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Quark Pharmaceuticals
Study Sponsor  ICMJE Quark Pharmaceuticals
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Quark Pharmaceuticals
Verification Date October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP