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Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

Primary Purpose

Macular Degeneration

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pegaptanib sodium
Sponsored by
Eyetech Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring AMD, Age-Related Macular Degeneration, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320. Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of < 12 total disc areas, of which at least 50% must be active CNV. Any subretinal hemorrhage must comprise no more than 50% of total lesion size. General Criteria: Patients of either gender, aged greater than 50 years. Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. Written informed consent. Exclusion Criteria: Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. Patients who are eligible for PDT with Visudyne Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.

Sites / Locations

  • Doheny Eye Institute
  • Connecticut Retina Consultants, L.L.C.
  • New England Retina Associates
  • Retina Health Center
  • Retina Associates
  • Cumberland Valley Retina Center
  • New England Eye Center
  • Ophthalmic Consultants of Boston
  • Associated Retinal Consultants
  • Eye Foundation of Kansas City
  • The Eye Center of Concord
  • Vitreo- Retinal Assoc. of NJ
  • Retina Associates of New Jersey, P.A.
  • L.I. Vitreo-Retinal Consultants
  • Retina Associates of Cleveland Inc.
  • Dean A. McGee Eye Institute
  • The Casey Eye Institute
  • Palmetto Retina Center
  • Valley Retina Associates, P.A.
  • University of Vermont College of Medicine

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
July 21, 2004
Last Updated
August 29, 2005
Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00088192
Brief Title
Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)
Official Title
An Open Label, Non-Comparative Protocol for Use of Intravitreous Pegaptanib Sodium Injection Every 6 Weeks in Patients With Exudative Age-Related Macular Degeneration (AMD)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2005
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer

4. Oversight

5. Study Description

Brief Summary
To provide Pegaptanib sodium injection to patients with subfoveal choroidal neovascularization (CNV) secondary to AMD, who are unable to participate in any of the Sponsor's other clinical studies with this drug for AMD, until such time as the patient's lesion is considered to have resolved or stabilized in the opinion of the treating ophthalmologist, or product becomes commercially available.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
AMD, Age-Related Macular Degeneration, Exudative Subfoveal Age Related Macular Degeneration with Subfoveal Choroidal Neovascularization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
pegaptanib sodium

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Best corrected visual acuity in the study eye between 20/40 and 20/320. Subfoveal choroidal neovascularization, secondary to age related macular degeneration, with a total lesion size [including blood, scar/atrophy & neovascularization] of < 12 total disc areas, of which at least 50% must be active CNV. Any subretinal hemorrhage must comprise no more than 50% of total lesion size. General Criteria: Patients of either gender, aged greater than 50 years. Women must be using two forms of effective contraception, or be post-menopausal for at least 12 months prior to study entry, or surgically sterile. If of child-bearing potential, a serum pregnancy test must be performed within 48 hours prior to treatment and the result made available prior to treatment initiation. The two forms of effective contraception must be implemented during the study and for at least 60 days following the last dose of test medication. Written informed consent. Exclusion Criteria: Any subfoveal scarring or atrophy and no more than 25% of the total lesion size may be made up of scarring or atrophy. Patients who are eligible for PDT with Visudyne Patients who are eligible for any other of the Sponsor's ongoing AMD studies still open to enrollment.
Facility Information:
Facility Name
Doheny Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Connecticut Retina Consultants, L.L.C.
City
Bridgeport
State/Province
Connecticut
ZIP/Postal Code
06606
Country
United States
Facility Name
New England Retina Associates
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Retina Health Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Retina Associates
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70155
Country
United States
Facility Name
Cumberland Valley Retina Center
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
New England Eye Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Associated Retinal Consultants
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Eye Foundation of Kansas City
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
The Eye Center of Concord
City
Concord
State/Province
New Hampshire
ZIP/Postal Code
03301
Country
United States
Facility Name
Vitreo- Retinal Assoc. of NJ
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
Facility Name
Retina Associates of New Jersey, P.A.
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
L.I. Vitreo-Retinal Consultants
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Retina Associates of Cleveland Inc.
City
Lakewood
State/Province
Ohio
ZIP/Postal Code
44107
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
The Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Palmetto Retina Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29204
Country
United States
Facility Name
Valley Retina Associates, P.A.
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
University of Vermont College of Medicine
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States

12. IPD Sharing Statement

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Intravitreous Pegaptanib Sodium Injection in Patients With Exudative Age-Related Macular Degeneration (AMD)

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