Phase 3 Study to Evaluate Anecortave Acetate vs. Visudyne for the Treatment of the Wet Form of AMD

Alcon

Status and phase: Completed; Phase 3

Conditions: Macular Degeneration

Treatments: Other: Photodynamic Therapy (PDT); Drug: Anecortave Acetate 15 mg sterile suspension

Study type: Interventional

Funder types: Industry

Identifiers

NCT00041483

C-01-99

Details and patient eligibility

About

The purpose of this study is to demonstrate that Anecortave Acetate is as effective after twelve months of treatment as photodynamic therapy (PDT) with Visudyne in patients eligible for initial PDT treatment for wet age-related macular degeneration.

Enrollment: 530 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Patients of any race, either gender, aged 50 years and above, diagnosed with subfoveal CNV due to AMD with best corrected logMAR visual acuity of 20/40 (snellen equivalent) to 20/400 (Snellen equivalent) in the study eye. Clinically relevant concomitant diseases will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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530 participants in 2 patient groups

Anecortave and Sham PDT

Active Comparator group

Treatment:

Drug: Anecortave Acetate 15 mg sterile suspension

Other: Photodynamic Therapy (PDT)

PDT and Sham Anecortave Acetate

Active Comparator group

Treatment:

Drug: Anecortave Acetate 15 mg sterile suspension

Other: Photodynamic Therapy (PDT)