NCT00333216

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started May 2005

Typical duration 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

May 1, 2005

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 2, 2006

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

November 28, 2012

Status Verified

December 1, 2011

Enrollment Period

3.6 years

First QC Date

May 31, 2006

Last Update Submit

November 27, 2012

Conditions

AMD

Outcome Measures

Primary Outcomes (1)

  • Proportion of patients with sight-threatening CNV in study eye

    Month 48

Secondary Outcomes (2)

  • Time to development of sight-threatening CNV

    Up to 48 months

  • Proportion of patients with stable vision

    Up to 48 months

Study Arms (3)

15 mg Anecortave Acetate

EXPERIMENTAL

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

30 mg Anecortave Acetate

EXPERIMENTAL

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

Anecortave Acetate Vehicle

SHAM COMPARATOR

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

Other: Anecortave Acetate Vehicle

Interventions

Anecortave Acetate Sterile Suspension, 30 mg/mLDRUG

Posterior juxtascleral administration of suspension

15 mg Anecortave Acetate
Anecortave Acetate Sterile Suspension, 60 mg/MLDRUG

Posterior juxtascleral administration of suspension

30 mg Anecortave Acetate
Anecortave Acetate VehicleOTHER

Sham posterior juxtascleral administration of suspension

Anecortave Acetate Vehicle

Eligibility Criteria

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

You may qualify if:

  • Dry AMD in study eye, Wet AMD in non-study eye;

You may not qualify if:

  • Under 50;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, 76134, United States

Location

MeSH Terms

Interventions

anecortave acetate

Study Officials

  • Terry Wiernas, PhD

    Study Director

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

May 31, 2006

First Posted

June 2, 2006

Study Start

May 1, 2005

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 28, 2012

Record last verified: 2011-12

Locations

US(1)