NCT00332657

Brief Summary

The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
36

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2006

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

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
3 months until next milestone

Study Start

First participant enrolled

September 1, 2006

Completed
2.3 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

September 1, 2009

Enrollment Period

2.3 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 choroidal neovascularization (CNV) in study eye

    Month 48

Secondary Outcomes (1)

  • Time to development of sight-threatening CNV

    Timepoint

Study Arms (3)

Anecortave Acetate, 15 mg

EXPERIMENTAL

One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.

Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL

Anecortave Acetate, 30 mg

EXPERIMENTAL

One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.

Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL

Anecortave Acetate Vehicle

SHAM COMPARATOR

One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.

Other: Anecortave Acetate Vehicle

Interventions

Anecortave Acetate Sterile Suspension, 30 mg/mLDRUG

One 0.5 mL injection into the PJD at 6-month intervals for 42 months

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

One 0.5 mL injection into the PJD at 6-month intervals for 42 months

Anecortave Acetate, 30 mg
Anecortave Acetate VehicleOTHER

One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were 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 in study eye, Wet AMD non-study eye.

You may not qualify if:

  • Under 50.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

India

Bangalore, 76134, India

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

September 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 28, 2012

Record last verified: 2009-09

Locations

IN(1)