Treatment of Age-Related Macular Degeneration With Anecortave Acetate

NCT ID: NCT00211458

Last Updated: 2012-10-25

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

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

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The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control classic neovascularization following failure of treatment with photodynamic therapy using Visudyne.

Detailed Description

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Conditions

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Macular Degeneration

Keywords

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Age-Related Macular Degeneration

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anecortave Acetate Sterile Suspension (15 mg)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Clinical diagnosis of patients that previously had a failure of treatment with photodynamic therapy using Visudyne.
2. Patients must be at least 50 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart

Exclusion Criteria

1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
2. Patients who have undergone intraocular surgery within the last 2 months.
3. Patient participating in any other investigational drug study.
4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
5. Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access).
6. Patient with significant liver disease or uremia.
7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study
9. Patient has had insertion of scleral buckle in the study eye
10. Patient has received radiation treatment
11. Patient is on anticoagulant therapy with the exception of aspirin
12. Patient is pregnant or nursing.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role collaborator

Manhattan Eye, Ear & Throat Hospital

OTHER

Sponsor Role lead

Responsible Party

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Joan

Jason Slakter, M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason S Slakter, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Eye, Ear & Throat Hospital

Locations

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Manhattan Eye, Ear & Throat Hospital

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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Failed PDT treated with AA

Identifier Type: -

Identifier Source: org_study_id