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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Quark Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00725686
First received: July 28, 2008
Last updated: October 5, 2012
Last verified: October 2012

July 28, 2008
October 5, 2012
February 2007
November 2010   (final data collection date for primary outcome measure)
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 ]
To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection [ Time Frame: Monthly ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00725686 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
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").

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

Dose escalation safety study

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age-Related Macular Degeneration
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
Other Name: REDD14NP
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
54
November 2010
November 2010   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Israel
 
NCT00725686
B0451008, QRK.003
Yes
Quark Pharmaceuticals
Quark Pharmaceuticals
Pfizer
Study Director: Pfizer CT.gov Call Center Pfizer
Quark Pharmaceuticals
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP