NCT00307398

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,596

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Mar 2004

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 28, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

November 28, 2012

Status Verified

May 1, 2009

Enrollment Period

4.8 years

First QC Date

March 24, 2006

Last Update Submit

November 27, 2012

Conditions

Dry AMD

Keywords

AMDDry AMDDrusenCNV

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with sight-threatening choroidal neovascularization (ST-CNV) in the study eye at 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.

    Month 48

Study Arms (2)

AL-3789

EXPERIMENTAL

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

Anecortave Acetate Vehicle

SHAM COMPARATOR

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

Interventions

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

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.

AL-3789
Anecortave Acetate VehicleOTHER

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

Anecortave Acetate Vehicle

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study Centers in the United States and Globally

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Interventions

anecortave acetateAL 3789

Study Officials

  • Patricia Zilliox

    Study Manager

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 24, 2006

First Posted

March 28, 2006

Study Start

March 1, 2004

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

November 28, 2012

Record last verified: 2009-05

Locations

US(1)