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Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)

NCT ID: NCT00211419

Last Updated: 2012-10-24

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

PHASE1

Study Classification

INTERVENTIONAL

Brief Summary

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The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following photodynamic therapy with verteporfin for the treatment of exudative age-related macular degeneration (AMD).

Detailed Description

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Conditions

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Maculopathy, Age-Related

Keywords

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Exudative Age-Related Macular Degeneration AMD

Study Design

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Allocation Method

NON_RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Anecortave Acetate 15 mg

Intervention Type DRUG

Triamcinolone Acetate 4 mg

Intervention Type DRUG

Photodynamic Therapy with Verteporfin

Intervention Type PROCEDURE

Thermal Laser

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. A male or female with evidence of exudative age-related macular degeneration with clinical/angiographic/optical coherence tomography (OCT) findings of subfoveal choroidal neovascularization (CNV) which has not responded to current therapy
2. Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640
3. Patient must be willing and able to comply with the protocol and provide informed consent.

Exclusion Criteria

1. Patients on intravenous, subcutaneous, or anticoagulant therapy (with the exception of aspirin and antiplatelet therapy) and cannot take a 5 day holiday from therapy prior to the injection procedure. Note: Patients on oral anticoagulant therapy may be considered to participate if the physician responsible for monitoring the anticoagulant therapy agrees that the patient may take a 5 day holiday from therapy prior to each anecortave injection. The attending doctor must notify the principal investigator and this notification will be made part of the source documentation. Anticoagulant therapy may resume either the evening of or the morning after the injection procedure.
2. Patient with known glaucoma or steroid induced ocular hypertension
3. Intraocular pressures of 21 mmHg or greater at time of entry into the study
4. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions
5. Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye
6. Patient participating in any other investigational drug study
7. Inability to obtain photographs to document CNV (including difficulty with venous access)
8. Concomitant oral steroids or topical ophthalmic steroid use
9. Sub-Tenon's injection of steroids within the past 6 months
10. Patient with significant liver disease or uremia
11. Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone
12. Patient is pregnant or nursing
13. Age less than 50 years old
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

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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Double Injection

Identifier Type: -

Identifier Source: org_study_id