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Sponsors and Collaborators: |
Eyetech Pharmaceuticals Pfizer |
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Information provided by: | Eyetech Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00134667 |
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 |
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Age-Related Macular Degeneration |
Drug: Photodynamic Therapy (PDT) with Visudyne (verteporfin) Drug: Macugen (pegaptanib sodium) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Safety/Efficacy Study |
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) |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | EOP1012 |
Study First Received: | August 24, 2005 |
Last Updated: | January 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00134667 |
Health Authority: | United States: Food and Drug Administration |
AMD Age-Related Macular Degeneration Macular Degeneration Macugen Photodynamic Therapy PDT |
Visudyne pegaptanib sodium verteporfin Predominantly Classic Age-Related Macular Degeneration (AMD) |
Eye Diseases Verteporfin Retinal Degeneration |
Macular Degeneration Retinal Diseases Retinal degeneration |
Photosensitizing Agents Radiation-Sensitizing Agents Therapeutic Uses |
Physiological Effects of Drugs Dermatologic Agents Pharmacologic Actions |