NCT00051129

Brief Summary

The purpose of this study was to evaluate anecortave acetate compared to placebo for maintenance of visual acuity after 24 months of treatment in patients with subfovial choroidal neovascularization (CNV) due to exudative age-related macular degeneration (AMD).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
291

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Shorter than P25 for phase_3

Status
completed

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

January 3, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 7, 2003

Completed
4 years until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 28, 2012

Status Verified

August 1, 2008

Enrollment Period

1.3 years

First QC Date

January 3, 2003

Last Update Submit

November 27, 2012

Conditions

Macular DegenerationMaculopathy, Age-RelatedAge-Related MaculopathiesAge-Related MaculopathyMaculopathies, Age-Related

Keywords

AMDanecortave acetatewet AMDage-related macular degenerationMacular DegenerationMaculopathy, Age-RelatedAge-Related MaculopathiesAge-Related MaculopathyMaculopathies, Age-Related

Outcome Measures

Primary Outcomes (1)

  • Mean change from baseline in logMAR visual acuity score at 12 months

    Month 12

Study Arms (2)

Anecortave Acetate

EXPERIMENTAL

Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)

Drug: Anecortave Acetate 15 mg sterile suspension

Anecortave Acetate Vehicle

PLACEBO COMPARATOR

Posterior juxtascleral injection in the study eye at 6 month intervals (Day 0, Month 6, Month 12, Month 18)

Other: Anecortave Acetate Vehicle

Interventions

Anecortave Acetate 15 mg sterile suspensionDRUG

0.5 ml of 30 mg/ml administered as a posterior juxtascleral injection

Anecortave Acetate
Anecortave Acetate VehicleOTHER

Administered as a posterior juxtascleral injection

Anecortave Acetate Vehicle

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of exudative AMD and a primary or recurrent subfoveal CNV lesion in the study eye.

You may not qualify if:

  • Under 50 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Macular Degeneration

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

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

January 3, 2003

First Posted

January 7, 2003

Study Start

January 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 28, 2012

Record last verified: 2008-08