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Anecortave Acetate Risk-Reduction Trial (AART)

NCT ID: NCT00333216

Last Updated: 2012-11-28

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

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-05-31

Study Completion Date

2008-12-31

Brief Summary

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The purpose of this study was to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of non-exudative (dry) age-related macular degeneration in patients who are at risk for progressing to exudative (wet) age-related macular degeneration.

Detailed Description

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Conditions

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AMD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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15 mg Anecortave Acetate

Anecortave Acetate Sterile Suspension, 30 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 30 mg/mL

Intervention Type DRUG

Posterior juxtascleral administration of suspension

30 mg Anecortave Acetate

Anecortave Acetate Sterile Suspension, 60 mg/mL, one injection of 0.5 mL in the study eye every 6 months for 48 months

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/ML

Intervention Type DRUG

Posterior juxtascleral administration of suspension

Anecortave Acetate Vehicle

Anecortave Acetate Vehicle, one sham injection in the study eye every 6 months for 48 months

Group Type SHAM_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

Sham posterior juxtascleral administration of suspension

Interventions

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Anecortave Acetate Sterile Suspension, 30 mg/mL

Posterior juxtascleral administration of suspension

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 60 mg/ML

Posterior juxtascleral administration of suspension

Intervention Type DRUG

Anecortave Acetate Vehicle

Sham posterior juxtascleral administration of suspension

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dry AMD in study eye, Wet AMD in non-study eye;

Exclusion Criteria

* Under 50;
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

Principal Investigators

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Terry Wiernas, PhD

Role: STUDY_DIRECTOR

Study Director

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-04-30

Identifier Type: -

Identifier Source: org_study_id