A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration

NCT ID: NCT00346957

Last Updated: 2012-03-06

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

PHASE2

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-04-30

Study Completion Date

2003-04-30

Brief Summary

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The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.

Detailed Description

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Conditions

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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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Anecortave Acetate 30

Group Type EXPERIMENTAL

Anecortave acetate 30 mg

Intervention Type DRUG

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate 15

Group Type EXPERIMENTAL

Anecortave Acetate 15 mg

Intervention Type DRUG

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate 3

Group Type EXPERIMENTAL

Anecortave Acetate 3 mg

Intervention Type DRUG

0.5ml administered onto the sclera once every six months for 24 months

Anecortave Acetate Vehicle

Group Type PLACEBO_COMPARATOR

Anecortave Acetate Vehicle

Intervention Type OTHER

0.5ml administered onto the sclera once every six months for 24 months

Interventions

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Anecortave acetate 30 mg

0.5ml administered onto the sclera once every six months for 24 months

Intervention Type DRUG

Anecortave Acetate 15 mg

0.5ml administered onto the sclera once every six months for 24 months

Intervention Type DRUG

Anecortave Acetate 3 mg

0.5ml administered onto the sclera once every six months for 24 months

Intervention Type DRUG

Anecortave Acetate Vehicle

0.5ml administered onto the sclera once every six months for 24 months

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Ages 50 years and over
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

Other Identifiers

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C-98-03

Identifier Type: -

Identifier Source: org_study_id

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