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

NCT ID: NCT00134667

Last Updated: 2007-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2008-10-31

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.

Conditions

Age-Related Macular Degeneration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Photodynamic Therapy (PDT) with Visudyne (verteporfin)

Intervention Type: DRUG

Macugen (pegaptanib sodium)

Intervention Type: DRUG

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

Eyetech Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Locations

Retina Centers, P.C., Northwest Location

Tucson, Arizona, United States

Countries

United States

Other Identifiers

EOP1012

Identifier Type: -

Identifier Source: org_study_id