Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
NCT00725686
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- 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
- 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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Descriptive Information | ||||
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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 | 54 | |||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
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 |
| |||
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 |