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

NCT ID: NCT00041483

Last Updated: 2014-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anecortave and Sham PDT

Group Type ACTIVE_COMPARATOR

Anecortave Acetate 15 mg sterile suspension

Intervention Type DRUG

Photodynamic Therapy (PDT)

Intervention Type OTHER

PDT and Sham Anecortave Acetate

Group Type ACTIVE_COMPARATOR

Anecortave Acetate 15 mg sterile suspension

Intervention Type DRUG

Photodynamic Therapy (PDT)

Intervention Type OTHER

Interventions

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Anecortave Acetate 15 mg sterile suspension

Intervention Type DRUG

Photodynamic Therapy (PDT)

Intervention Type OTHER

Eligibility Criteria

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Inclusion 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.

Exclusion Criteria

Clinically relevant concomitant diseases will be excluded.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-01-99

Identifier Type: -

Identifier Source: org_study_id

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