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

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

Detailed Description
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Dose escalation safety study

Official Title
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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).

Conditions
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Age-Related Macular Degeneration

Intervention / Treatment
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* Drug: PF-04523655


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of PF-04523655 when administered as a single intravitreal injection |  | Over a 24-Month Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choroidal Neovascularization (CNV) WET AMD