CClinicalTrials.gg
TerminatedNCT00333216Updated Nov 28, 2012

Anecortave Acetate Risk-Reduction Trial (AART)

A Phase 3 interventional study of Anecortave Acetate Sterile Suspension, 30 mg/mL and Anecortave Acetate Sterile Suspension, 60 mg/ML in AMD, sponsored by Alcon Research. Terminated at 1 site in United States. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2012-11-28.

Sponsored by Alcon Research · Phase 3, Interventional, and Prevention

Why this study was terminated
Lack of efficacy
Phase
Phase 3
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • AMD
03

In context

Lead sponsor

Alcon Research is the lead sponsor of 608 studies on the registry; 9 are open to participants now.

Of its 109 completed or terminated interventional studies of FDA-regulated products, 99 (91%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Dry AMD in study eye, Wet AMD in non-study eye;
  • Other protocol-defined inclusion criteria may apply.

Exclusion criteria

Exclusion Criteria:

  • Under 50;
  • Other protocol-defined exclusion criteria may apply.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
24 participants (actual)

Study arms

  • Experimental
    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

    Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

  • Experimental
    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

    Drug: Anecortave Acetate Sterile Suspension, 60 mg/ML

  • Sham comparator
    Anecortave Acetate Vehicle

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

    Other: Anecortave Acetate Vehicle

Interventions

  • DrugAnecortave Acetate Sterile Suspension, 30 mg/mL

    Posterior juxtascleral administration of suspension

  • DrugAnecortave Acetate Sterile Suspension, 60 mg/ML

    Posterior juxtascleral administration of suspension

  • OtherAnecortave Acetate Vehicle

    Sham posterior juxtascleral administration of suspension

06

What researchers measure

Primary outcomes

  1. Proportion of patients with sight-threatening CNV in study eye

    Time frame: Month 48

Secondary outcomes

  1. Time to development of sight-threatening CNV

    Time frame: Up to 48 months

  2. Proportion of patients with stable vision

    Time frame: Up to 48 months

07

Study locations

1 site
  • Contact Alcon Call Center for Trial Locations
    Fort Worth, Texas 76134, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00333216
Lead sponsor
Alcon Research
Responsible party
Sponsor
First posted
Jun 2, 2006
Start date
May 2005
Primary completion
Dec 2008
Completion
Dec 2008
Last update
Nov 28, 2012

Study contacts

Terry Wiernas, PhD
study director · Study Director

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.

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