Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)

NCT ID: NCT00299507

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study was to evaluate the effect of the dose concentration and administration frequency of Anecortave Acetate (AA) on visual acuity (VA) and lesion size when administered by posterior juxtascleral depot (PJD) every 3 months (AA 15 mg) or 6 months (AA 15 mg, AA 30 mg) in patients with exudative age-related macular degeneration (AMD).

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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exudative AMD age-related macular degeneration (AMD)

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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15 mg Anecortave Acetate, 3 month intervals

Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 3 month intervals (0, 3, 6, 9, 12, 15, 18 months).

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 30 mg/mL

Intervention Type DRUG

One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals

15 mg Anecortave Acetate, 6 month intervals

Anecortave Acetate Sterile Suspension, 30 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 30 mg/mL

Intervention Type DRUG

One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals

30 mg Anecortave Acetate, 6 month intervals

Anecortave Acetate Sterile Suspension, 60 mg/mL, one 0.5 mL posterior juxtascleral depot injection at 6 month intervals (3, 9, 15, 21 months).

Group Type EXPERIMENTAL

Anecortave Acetate Sterile Suspension, 60 mg/mL

Intervention Type DRUG

One 0.5 mL posterior juxtascleral depot injection at 6 month intervals

Anecortave Acetate Vehicle

One 0.5 mL sham injection of Anecortave Acetate Vehicle at 6 month intervals (3, 9, 15, 21 months).

Group Type SHAM_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

One 0.5 mL sham injection at 6 month intervals

Interventions

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Anecortave Acetate Sterile Suspension, 30 mg/mL

One 0.5 mL posterior juxtascleral depot injection at 3 or 6 month intervals

Intervention Type DRUG

Anecortave Acetate Sterile Suspension, 60 mg/mL

One 0.5 mL posterior juxtascleral depot injection at 6 month intervals

Intervention Type DRUG

Anecortave Acetate Vehicle

One 0.5 mL sham injection at 6 month intervals

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Clinical diagnosis of exudative AMD and a primary or recurrent (after laser photocoagulation) subfoveal choroidal neovascularization (CNV) lesion.

Exclusion Criteria

* Less than 50 years of age.
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

Principal Investigators

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Alcon Investigators

Role: PRINCIPAL_INVESTIGATOR

Alcon Research

Patricia Zilliox, Ph.D.

Role: STUDY_DIRECTOR

Alcon Research

Locations

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Alcon Study Sites

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-04-59

Identifier Type: -

Identifier Source: org_study_id