Anecortave Acetate Risk-Reduction Trial (AART)

Sponsor

Alcon Research (Industry)

Overall Status

Terminated

CT.gov ID

NCT00307398

Collaborator

(none)

2,596

Enrollment

Location

Arms

58.1

Duration (Months)

44.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Dry AMD	Drug: Anecortave Acetate (AL-3789) sterile suspension, 15 mg or 30 mg Other: Anecortave Acetate Vehicle	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

2596 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Study Start Date :

Mar 1, 2004

Actual Primary Completion Date :

Jan 1, 2009

Actual Study Completion Date :

Jan 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AL-3789 One injection to the study eye by the posterior juxtascleral depot procedure at 6-month intervals for 42 months.	Drug: 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.
Sham Comparator: 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.	Other: Anecortave Acetate Vehicle One 0.5 mL sham injection at 6-month intervals. Syringe containing AA vehicle was not inserted into the eye.

Arm

Intervention/Treatment

Experimental: AL-3789

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

Drug: 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.

Sham Comparator: 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.

Other: Anecortave Acetate Vehicle

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

Outcome Measures

Primary Outcome Measures

Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at Month 48 [Month 48]
ST-CNV is defined as CNV or a portion of CNV within 2500 microns of the foveal center, as evidenced by digital angiography at the clinical site.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Age
Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Study Centers in the United States and Globally	Fort Worth	Texas	United States	76134

Sponsors and Collaborators

Alcon Research

Investigators

Study Director: Patricia Zilliox, Study Manager

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alcon Research

ClinicalTrials.gov Identifier:

NCT00307398

Other Study ID Numbers:

C-02-60

First Posted:

Mar 28, 2006

Last Update Posted:

Nov 28, 2012

Last Verified:

May 1, 2009

Keywords provided by Alcon Research

Additional relevant MeSH terms:

Hydrocortisone

Anecortave

Study Results

No Results Posted as of Nov 28, 2012