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

Purpose

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

Condition	Intervention	Phase
Age-Related Macular Degeneration	Drug: PF-04523655	Phase 1

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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").

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Macular Degeneration

U.S. FDA Resources

Further study details as provided by Quark Pharmaceuticals:

Primary Outcome Measures:

To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Over a 24-Month Period ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

To describe anatomical changes in the retina and choroid following the administration of PF-04523655 [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655 [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	54
Study Start Date:	February 2007
Study Completion Date:	November 2010
Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Intervention Details:

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

Detailed Description:

Dose escalation safety study

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00725686

Locations

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
Israel
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

Pfizer

Investigators

Study Director:

Pfizer CT.gov Call Center

Pfizer

More Information

Additional Information:

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Quark Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00725686 History of Changes
Obsolete Identifiers:	NCT00455481
Other Study ID Numbers:	B0451008, QRK.003
Study First Received:	July 28, 2008
Last Updated:	October 5, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Quark Pharmaceuticals:

Choroidal Neovascularization (CNV) "WET" AMD

Additional relevant MeSH terms:

Macular Degeneration
Neovascularization, Pathologic
Choroidal Neovascularization
Retinal Degeneration
Retinal Diseases

Eye Diseases
Metaplasia
Pathologic Processes
Choroid Diseases
Uveal Diseases

ClinicalTrials.gov processed this record on May 21, 2013