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

This study has been terminated.
Sponsor:
Collaborator:
Pfizer
Information provided by:
Eyetech Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00134667
First received: August 24, 2005
Last updated: January 12, 2007
Last verified: January 2007
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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)

Resource links provided by NLM:


Further study details as provided by Eyetech Pharmaceuticals:

Estimated Enrollment: 360
Study Start Date: March 2005
Estimated Study Completion Date: October 2008
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00134667     History of Changes
Other Study ID Numbers: EOP1012
Study First Received: August 24, 2005
Last Updated: January 12, 2007
Health Authority: United States: Food and Drug Administration

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
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 26, 2014