Back to resultsMacugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)
Primary Purpose
Age-Related Macular Degeneration
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Photodynamic Therapy (PDT) with Visudyne (verteporfin)
Macugen (pegaptanib sodium)
Sponsored by
About this trial
This is an interventional treatment trial for Age-Related Macular Degeneration focused on measuring AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, Photodynamic Therapy, PDT, Visudyne, pegaptanib sodium, verteporfin, Predominantly Classic, Age-Related Macular Degeneration (AMD)
Eligibility Criteria
Inclusion Criteria: Subjects of either gender; aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition Best corrected visual acuity in the study eye between 20/40 and 20/200 Exclusion Criteria: Any prior PDT with Visudyne to the study eye Any previous AMD thermal laser therapy to the study eye
Sites / Locations
- Retina Centers, P.C., Northwest Location
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00134667
First Posted
August 24, 2005
Last Updated
January 12, 2007
Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
1. Study Identification
Unique Protocol Identification Number
NCT00134667
Brief Title
Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)
Official Title
A Phase IIIb/IV Randomized, Double-Masked, Active Controlled, Dose-Ranging, Multi-Center Comparative Trial, in Parallel Groups, to Compare the Safety and Efficacy of Intravitreal Injections of Pegaptanib Sodium (Macugen) Given Every 6 Weeks for 102 Weeks, to Pegaptanib Sodium Plus Photodynamic Therapy (PDT) With Visudyne, in Patients With Exudative Age-Related Macular Degeneration (AMD)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2007
Overall Recruitment Status
Terminated
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2008 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Eyetech Pharmaceuticals
Collaborators
Pfizer
4. Oversight
5. Study Description
Brief Summary
The purpose of the trial is to compare whether Macugen (pegaptanib sodium) in combination with PDT with Visudyne (verteporfin) is safe and effective in slowing down the leakage of fluid within the eye and thereby stabilizing or improving vision when compared to Macugen alone. Patients must be recently diagnosed with predominantly classic wet AMD and must be eligible for PDT.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degeneration
Keywords
AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, Photodynamic Therapy, PDT, Visudyne, pegaptanib sodium, verteporfin, Predominantly Classic, Age-Related Macular Degeneration (AMD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
360 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Photodynamic Therapy (PDT) with Visudyne (verteporfin)
Intervention Type
Drug
Intervention Name(s)
Macugen (pegaptanib sodium)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects of either gender; aged 50 years or greater.
Subfoveal choroidal neovascularization (CNV) due to AMD with predominantly classic lesion composition
Best corrected visual acuity in the study eye between 20/40 and 20/200
Exclusion Criteria:
Any prior PDT with Visudyne to the study eye
Any previous AMD thermal laser therapy to the study eye
Facility Information:
Facility Name
Retina Centers, P.C., Northwest Location
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704-5614
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)
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