Anecortave Acetate Risk Reduction Trial (AART)

NCT ID: NCT00332657

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

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

Brief Summary

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

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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Anecortave Acetate, 15 mg

One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 30 mg/mL

Intervention Type DRUG

One 0.5 mL injection into the PJD at 6-month intervals for 42 months

Anecortave Acetate, 30 mg

One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/mL

Intervention Type DRUG

One 0.5 mL injection into the PJD at 6-month intervals for 42 months

Anecortave Acetate Vehicle

One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

Group Type SHAM_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

Interventions

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Anecortave Acetate Sterile Suspension, 30 mg/mL

One 0.5 mL injection into the PJD at 6-month intervals for 42 months

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 60 mg/mL

One 0.5 mL injection into the PJD at 6-month intervals for 42 months

Intervention Type DRUG

Anecortave Acetate Vehicle

One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dry AMD in study eye, Wet AMD 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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India

Bangalore, , India

Site Status

Countries

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India

Other Identifiers

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C-05-34

Identifier Type: -

Identifier Source: org_study_id