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

Eyetech Pharmaceuticals

Status and phase: Terminated; Phase 4

Conditions: Age-Related Macular Degeneration

Treatments: Drug: Photodynamic Therapy (PDT) with Visudyne (verteporfin); Drug: Macugen (pegaptanib sodium)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00134667

EOP1012

Details and patient eligibility

About

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.

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind