Clinical trial NCT00725686: Study of PF-04523655 (REDD14NP) In Subjects With Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (Wet AMD)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Age-Related Macular Degeneration
Keywords: Choroidal Neovascularization (CNV) "WET" AMD
Lead sponsor: Quark Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2008-07-30
Enrollment: 54
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: Dose escalation safety study

Eligibility criteria: 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.

Primary outcomes:
measure: To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection
timeFrame: Over a 24-Month Period
Secondary outcomes:
measure: To describe anatomical changes in the retina and choroid following the administration of PF-04523655
timeFrame: Day 14
measure: To determine the changes in visual acuity ETDRS chart after a single intravitreal injection of PF-04523655
timeFrame: Day 14
measure: 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
timeFrame: Monthly
measure: 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)
timeFrame: Day 14
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Pfizer Investigational Site
state: California
city: Pasadena
country: United States
facility: Pfizer Investigational Site
state: California
city: Walnut Creek
country: United States
facility: Pfizer Investigational Site
state: California
city: Miami
country: United States
facility: Pfizer Investigational Site
state: Florida
city: Aiea
country: United States
facility: Pfizer Investigational Site
state: Hawaii
city: Baltimore
country: United States
facility: Pfizer Investigational Site
state: Maryland
city: New York
country: United States
facility: Pfizer Investigational Site
state: New York
city: Cleveland
country: United States
facility: Pfizer Investigational Site
state: Ohio
city: Petah Tikva
country: Israel
facility: Pfizer Investigational Site
city: Rehovot
country: Israel
facility: Pfizer Investigational Site
city: Tel Aviv
country: Israel
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: