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

NCT00725686

Last updated date
Study Location
Pfizer Investigational Site
Beverly Hills, California, 90211, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Age-Related Macular Degeneration
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Pfizer Clinical Trials Contact Center

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[email protected]

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Age-Related Macular DegenerationStudy of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
NCT00725686
  1. Beverly Hills, California
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Advanced Information
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 CenterPfizer
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