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Anecortave Acetate in Subfoveal Choroidal Neovascularization (CNV) Due to Wet Age-Related Macular Degeneration (AMD)

NCT ID: NCT00051129

Last Updated: 2012-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

291 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2008-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Macular Degeneration Maculopathy, Age-Related Age-Related Maculopathies Age-Related Maculopathy Maculopathies, Age-Related

Keywords

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AMD anecortave acetate wet AMD age-related macular degeneration Macular Degeneration Maculopathy, Age-Related Age-Related Maculopathies Age-Related Maculopathy Maculopathies, Age-Related

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Anecortave Acetate

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

Group Type EXPERIMENTAL

Anecortave Acetate 15 mg sterile suspension

Intervention Type DRUG

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

Anecortave Acetate Vehicle

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

Group Type PLACEBO_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

Administered as a posterior juxtascleral injection

Interventions

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Anecortave Acetate 15 mg sterile suspension

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

Intervention Type DRUG

Anecortave Acetate Vehicle

Administered as a posterior juxtascleral injection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Under 50 years.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Countries

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United States

Other Identifiers

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C-02-27

Identifier Type: -

Identifier Source: org_study_id