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Macugen (Pegaptanib Sodium) Alone, Versus Macugen in Combination With PDT (Photodynamic Therapy) With Visudyne (Verteporfin) in Patients With Age-Related Macular Degeneration (AMD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00134667
Recruitment Status : Terminated
First Posted : August 25, 2005
Last Update Posted : January 15, 2007
Sponsor:
Collaborator:
Information provided by:

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.

Condition or disease Intervention/treatment Phase
Age-Related Macular Degeneration Drug: Photodynamic Therapy (PDT) with Visudyne (verteporfin) Drug: Macugen (pegaptanib sodium) Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : March 2005
Estimated Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00134667


Locations
United States, Arizona
Retina Centers, P.C., Northwest Location
Tucson, Arizona, United States, 85704-5614
Sponsors and Collaborators
Eyetech Pharmaceuticals
Pfizer
More Information

ClinicalTrials.gov Identifier: NCT00134667     History of Changes
Other Study ID Numbers: EOP1012
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: January 15, 2007
Last Verified: January 2007

Keywords provided by Eyetech Pharmaceuticals:
AMD
Age-Related Macular Degeneration
Macular Degeneration
Macugen
Photodynamic Therapy
PDT
Visudyne
pegaptanib sodium
verteporfin
Predominantly Classic
Age-Related Macular Degeneration (AMD)

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Verteporfin
Photosensitizing Agents
Dermatologic Agents