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Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.

Primary Purpose

Age-Related Macular Degenerations., Subfoveal Neovascularization.

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Anecortave Acetate
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Age-Related Macular Degenerations.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

Inclusion Criteria: Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser). Patients must be 18 years of age or older to receive treatment. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart. Exclusion Criteria: 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. Patient participating in any other investigational drug study. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. Inability to obtain photographs to document CNV (including difficulty with venous access). Patient with significant liver disease or uremia. Patient with known adverse reaction to fluorescein and indocyanine green or iodine. Patient has a history of any medical condition which would preclude scheduled visits or completion of study. Patient has had insertion of scleral buckle in the study eye. Patient has received radiation treatment. Patient is on anticoagulant therapy with the exception of aspirin. Patient is pregnant or nursing.

Sites / Locations

  • Manhattan Eye, Ear & Throat Hospital

Outcomes

Primary Outcome Measures

This study is designed to provide compassionate use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients where the lesions do not meet acceptable criteria for standard therapy.

Secondary Outcome Measures

mean change in VA(ETDRS), OCT, FA from baseline to 24 months

Full Information

First Posted
September 13, 2005
Last Updated
May 4, 2007
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00211484
Brief Title
Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these patients have. Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD).
Detailed Description
Patients will receive a sub-Tenon injection of 15mg of Anecortave acetate in their study eye with the use of a counter pressure device. Patients will then be followed for up to 24 months. The patients will have the option of extending their participation in the study for an additional 24 months. Statistical analysis will include comparison of patient follow-up visual acuity and angiographic data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-Related Macular Degenerations., Subfoveal Neovascularization.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Anecortave Acetate
Primary Outcome Measure Information:
Title
This study is designed to provide compassionate use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients where the lesions do not meet acceptable criteria for standard therapy.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
mean change in VA(ETDRS), OCT, FA from baseline to 24 months
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser). Patients must be 18 years of age or older to receive treatment. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart. Exclusion Criteria: 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. Patient participating in any other investigational drug study. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. Inability to obtain photographs to document CNV (including difficulty with venous access). Patient with significant liver disease or uremia. Patient with known adverse reaction to fluorescein and indocyanine green or iodine. Patient has a history of any medical condition which would preclude scheduled visits or completion of study. Patient has had insertion of scleral buckle in the study eye. Patient has received radiation treatment. Patient is on anticoagulant therapy with the exception of aspirin. Patient is pregnant or nursing.
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

Learn more about this trial

Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.

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