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CompletedNCT00725686Updated Oct 10, 2012

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

A Phase 1 interventional study of PF-04523655 in Age-Related Macular Degeneration, sponsored by Quark Pharmaceuticals. Completed at 11 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-10-10.

Sponsored by Quark Pharmaceuticals · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
54
Allocation
Not applicable
Ages
50 Years and older
Sex
All
01

Study summary

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

Read the detailed description

Dose escalation safety study

02

Conditions studied

  • Age-Related Macular Degeneration

Keywords

  • Choroidal Neovascularization (CNV) "WET" AMD
03

In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

This study's enrollment of 54 is close to the median of 51 across 985 interventional studies indexed under Macular Degeneration.

Browse Macular Degeneration studies →

Lead sponsor

Quark Pharmaceuticals is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
54 participants (actual)

Interventions

  • DrugPF-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

    Also known as: REDD14NP

06

What researchers measure

Primary outcomes

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

    Time frame: Over a 24-Month Period

Secondary outcomes

  1. To describe anatomical changes in the retina and choroid following the administration of PF-04523655

    Time frame: Day 14

  2. To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655

    Time frame: Day 14

  3. 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

  4. 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

07

Study locations

11 sites
  • Pfizer Investigational Site
    Beverly Hills, California 90211, United States
  • Pfizer Investigational Site
    Pasadena, California 91105, United States
  • Pfizer Investigational Site
    Walnut Creek, California 94598, United States
  • Pfizer Investigational Site
    Miami, Florida 33136, United States
  • Pfizer Investigational Site
    Aiea, Hawaii 96701, United States
  • Pfizer Investigational Site
    Baltimore, Maryland 21205, United States
  • Pfizer Investigational Site
    New York, New York 10022, United States
  • Pfizer Investigational Site
    Cleveland, Ohio 44195, United States
  • Pfizer Investigational Site
    Petah Tikva, 49100, Israel
  • Pfizer Investigational Site
    Rehovot, 76100, Israel
  • Pfizer Investigational Site
    Tel Aviv, 64239, Israel
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 10, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00725686
Lead sponsor
Quark Pharmaceuticals
Collaborators
Pfizer
Responsible party
Sponsor
First posted
Jul 30, 2008
Start date
Feb 2007
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Oct 10, 2012

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2012. You cannot join it, but the record below documents what was studied.

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