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

Sponsor

Quark Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00725686

Collaborator

Pfizer (Industry)

Enrollment

Locations

Duration (Months)

4.9

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Age-Related Macular Degeneration	Drug: PF-04523655	Phase 1

Detailed Description

Dose escalation safety study

Study Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (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").

Study Start Date :

Feb 1, 2007

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Outcome Measures

Primary Outcome Measures

To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [Over a 24-Month Period]

Secondary Outcome Measures

To describe anatomical changes in the retina and choroid following the administration of PF-04523655 [Day 14]
To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655 [Day 14]
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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Pfizer Investigational Site	Beverly Hills	California	United States	90211
2	Pfizer Investigational Site	Pasadena	California	United States	91105
3	Pfizer Investigational Site	Walnut Creek	California	United States	94598
4	Pfizer Investigational Site	Miami	Florida	United States	33136
5	Pfizer Investigational Site	Aiea	Hawaii	United States	96701
6	Pfizer Investigational Site	Baltimore	Maryland	United States	21205
7	Pfizer Investigational Site	New York	New York	United States	10022
8	Pfizer Investigational Site	Cleveland	Ohio	United States	44195
9	Pfizer Investigational Site	Petah Tikva		Israel	49100
10	Pfizer Investigational Site	Rehovot		Israel	76100
11	Pfizer Investigational Site	Tel Aviv		Israel	64239