Anecortave Acetate Risk-Reduction Trial (AART)

NCT ID: NCT00307398

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

2596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2009-01-31

Brief Summary

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A 48 month study of posterior juxtascleral administrations of Anecortave Acetate 15 or 30 mg or sham administration every 6 months.

Detailed Description

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Conditions

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Dry AMD

Keywords

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AMD Dry AMD Drusen CNV

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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AL-3789

One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.

Group Type EXPERIMENTAL

Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg

Intervention Type DRUG

One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.

Anecortave Acetate Vehicle

One sham injection to the study eye at 6-month intervals for 42 months. Syringe containing AA vehicle was 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. Syringe containing AA vehicle was not inserted into the eye.

Interventions

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Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg

One 0.5 mL injection of 30 mg/mL (AA 15 mg) or one 0.5 mL injection of 60 mg/mL (AA 30 mg) into a posterior juxtascleral depot (PJD) at 6-month intervals.

Intervention Type DRUG

Anecortave Acetate Vehicle

One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Dry AMD study eye, Wet AMD non-study eye.

Exclusion Criteria

* Age
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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Patricia Zilliox

Role: STUDY_DIRECTOR

Study Manager

Locations

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Study Centers in the United States and Globally

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-02-60

Identifier Type: -

Identifier Source: org_study_id