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

Age-Related Macular Degeneration Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00134667
• Other study ID #: EOP1012
• Status: Terminated
• Phase: Phase 4
• First received: August 24, 2005
• Last updated: January 12, 2007
• Start date: March 2005
• Est. completion date: October 2008

Study information

• Verified date: January 2007
• Source: Eyetech Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 360
• Est. completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Intervention

Drug:
• Photodynamic Therapy (PDT) with Visudyne (verteporfin)

• Macugen (pegaptanib sodium)

Locations

Country	Name	City	State
United States	Retina Centers, P.C., Northwest Location	Tucson	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Eyetech Pharmaceuticals	Pfizer

Country where clinical trial is conducted

United States,