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

Primary Purpose

Maculopathy, Age-Related

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate 15 mg
Triamcinolone Acetate 4 mg
Photodynamic Therapy with Verteporfin
Thermal Laser
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maculopathy, Age-Related focused on measuring Exudative Age-Related Macular Degeneration, AMD

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640 Patient must be willing and able to comply with the protocol and provide informed consent. Exclusion Criteria: 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. Patient with known glaucoma or steroid induced ocular hypertension Intraocular pressures of 21 mmHg or greater at time of entry into the study Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye Patient participating in any other investigational drug study Inability to obtain photographs to document CNV (including difficulty with venous access) Concomitant oral steroids or topical ophthalmic steroid use Sub-Tenon's injection of steroids within the past 6 months Patient with significant liver disease or uremia Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone Patient is pregnant or nursing Age less than 50 years old

Sites / Locations

  • Manhattan Eye, Ear & Throat Hospital

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
September 13, 2005
Last Updated
October 23, 2012
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00211419
Brief Title
Study of the Combination of Anecortave Acetate and Triamcinolone Acetonide for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
Official Title
Pilot Study of the Combination of Anecortave Acetate 15mg Delivered by Posterior Juxtascleral Injection and Triamcinolone Acetonide 4mg Delivered by Intravitreal Injection for the Treatment of Exudative Age-Related Macular Degeneration (AMD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research

4. Oversight

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maculopathy, Age-Related
Keywords
Exudative Age-Related Macular Degeneration, AMD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Masking
None (Open Label)
Allocation
Non-Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate 15 mg
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetate 4 mg
Intervention Type
Procedure
Intervention Name(s)
Photodynamic Therapy with Verteporfin
Intervention Type
Procedure
Intervention Name(s)
Thermal Laser

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Baseline best-corrected visual acuity (BCVA) 20/40 to 20/640 Patient must be willing and able to comply with the protocol and provide informed consent. Exclusion Criteria: 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. Patient with known glaucoma or steroid induced ocular hypertension Intraocular pressures of 21 mmHg or greater at time of entry into the study Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions Patients who have undergone intraocular surgery within last 2 months or capsulotomy within last month in study eye Patient participating in any other investigational drug study Inability to obtain photographs to document CNV (including difficulty with venous access) Concomitant oral steroids or topical ophthalmic steroid use Sub-Tenon's injection of steroids within the past 6 months Patient with significant liver disease or uremia Patient with known adverse reaction to indocyanine green, iodine, verteporfin, or triamcinolone Patient is pregnant or nursing Age less than 50 years old
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jason S Slakter, MD
Organizational Affiliation
Manhattan Eye, Ear & Throat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Eye, Ear & Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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

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