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

Age-Related Macular Degeneration Clinical Trial

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").

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00725686
• Other study ID #: B0451008
• Secondary ID: QRK.003
• Status: Completed
• Phase: Phase 1
• First received: July 28, 2008
• Last updated: October 5, 2012
• Start date: February 2007
• Est. completion date: November 2010

Study information

• Verified date: October 2012
• Source: Quark Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Description:

Dose escalation safety study

Other known NCT identifiers

• NCT00455481

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Neovascularization
• Macular Degeneration
• Neovascularization, Pathologic

Intervention

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

Locations

Country	Name	City	State
Israel	Pfizer Investigational Site	Petah Tikva
Israel	Pfizer Investigational Site	Rehovot
Israel	Pfizer Investigational Site	Tel Aviv
United States	Pfizer Investigational Site	Aiea	Hawaii
United States	Pfizer Investigational Site	Baltimore	Maryland
United States	Pfizer Investigational Site	Beverly Hills	California
United States	Pfizer Investigational Site	Cleveland	Ohio
United States	Pfizer Investigational Site	Miami	Florida
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Pasadena	California
United States	Pfizer Investigational Site	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Quark Pharmaceuticals	Pfizer

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection		Over a 24-Month Period	Yes
Secondary	To describe anatomical changes in the retina and choroid following the administration of PF-04523655		Day 14	Yes
Secondary	To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655		Day 14	Yes
Secondary	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		Monthly	Yes
Secondary	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)		Day 14	Yes

External Links

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