NCT00065728

Brief Summary

The purpose of this study is to investigate the long-term efficacy and safety of posterior juxtascleral injections of open label Anecortave Acetate 15mg administered every 6 months.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
111

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2003

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 1, 2003

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

September 16, 2013

Status Verified

May 1, 2009

Enrollment Period

5.3 years

First QC Date

July 31, 2003

Last Update Submit

September 4, 2013

Conditions

Macular Degeneration

Keywords

AMDage-related macular degenerationAnecortaveAcetateWet form of age-related macular degenerationCNVAnecortave Acetate

Outcome Measures

Primary Outcomes (2)

  • Percent of patients who maintained stable vision

    Stable vision is defined as \< 15-letter loss of best-corrected visual acuity scores)

    Month 24

  • Mean change in best-corrected visual acuity at Month 24 from baseline

    Baseline, Month 24

Study Arms (1)

Anecortave Acetate, 15 mg

EXPERIMENTAL

One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months

Drug: Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mL

Interventions

Anecortave Acetate (AL-3789) Sterile Suspension, 30 mg/mLDRUG

One 0.5 mL injection of 30 mg/mL Anecortave Acetate sterile suspension into the posterior juxtascleral depot at 6 month intervals for 18 months

Anecortave Acetate, 15 mg

Eligibility Criteria

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

You may qualify if:

  • Patients with subfoveal exudative age-related macular degeneration (AMD) who were previously enrolled in long-term studies with anecortave acetate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Belgium,France,Germany,Hungary,Italy,Netherlands,Poland,Spain,Sweden,UK

Central Contact Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

anecortave acetateAL 3789

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Terry Wiernas, PhD

    Alcon Research

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2003

First Posted

August 1, 2003

Study Start

June 1, 2003

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

September 16, 2013

Record last verified: 2009-05

Locations

US(1)