NCT00725686

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2007

Typical duration for phase_1

Geographic Reach
2 countries

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 28, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 30, 2008

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

3.8 years

First QC Date

July 28, 2008

Last Update Submit

October 5, 2012

Conditions

Age-Related Macular Degeneration

Keywords

Choroidal Neovascularization (CNV) "WET" AMD

Outcome Measures

Primary Outcomes (1)

  • To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection

    Over a 24-Month Period

Secondary Outcomes (4)

  • 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

Interventions

PF-04523655DRUG

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

Also known as: REDD14NP

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Pfizer Investigational Site

Beverly Hills, California, 90211, United States

Location

Pfizer Investigational Site

Pasadena, California, 91105, United States

Location

Pfizer Investigational Site

Walnut Creek, California, 94598, United States

Location

Pfizer Investigational Site

Miami, Florida, 33136, United States

Location

Pfizer Investigational Site

‘Aiea, Hawaii, 96701, United States

Location

Pfizer Investigational Site

Baltimore, Maryland, 21205, United States

Location

Pfizer Investigational Site

New York, New York, 10022, United States

Location

Pfizer Investigational Site

Cleveland, Ohio, 44195, United States

Location

Pfizer Investigational Site

Tel Aviv, Israel, 64239, Israel

Location

Pfizer Investigational Site

Petah Tikva, 49100, Israel

Location

Pfizer Investigational Site

Rehovot, 76100, Israel

Location

Related Links

MeSH Terms

Conditions

Macular DegenerationChoroidal Neovascularization

Interventions

PF-04523655

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesChoroid DiseasesUveal DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2008

First Posted

July 30, 2008

Study Start

February 1, 2007

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations

US(8)IL(3)