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

NCT ID: NCT00725686

Last Updated: 2012-10-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2010-11-30

Brief Summary

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

Detailed Description

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Dose escalation safety study

Conditions

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Age-Related Macular Degeneration

Keywords

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Choroidal Neovascularization (CNV) "WET" AMD

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Other Intervention Names

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REDD14NP

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role collaborator

Quark Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

Beverly Hills, California, United States

Site Status

Pfizer Investigational Site

Pasadena, California, United States

Site Status

Pfizer Investigational Site

Walnut Creek, California, United States

Site Status

Pfizer Investigational Site

Miami, Florida, United States

Site Status

Pfizer Investigational Site

‘Aiea, Hawaii, United States

Site Status

Pfizer Investigational Site

Baltimore, Maryland, United States

Site Status

Pfizer Investigational Site

New York, New York, United States

Site Status

Pfizer Investigational Site

Cleveland, Ohio, United States

Site Status

Pfizer Investigational Site

Tel Aviv, Israel, Israel

Site Status

Pfizer Investigational Site

Petah Tikva, , Israel

Site Status

Pfizer Investigational Site

Rehovot, , Israel

Site Status

Countries

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United States Israel

Related Links

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https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B0451008&StudyName=A%20Phase%201%20Dose%20Escalation%20Study%20of%20PF-04523655%20%28REDD14NP%29%20In%20Subjects%20with%20Choroidal%20Neovascularization%20%28CNV%29%20Secondary%20to%20Age-Relat

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

Other Identifiers

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QRK.003

Identifier Type: OTHER

Identifier Source: secondary_id

B0451008

Identifier Type: -

Identifier Source: org_study_id

NCT00455481

Identifier Type: -

Identifier Source: nct_alias