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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.

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ClinicalTrials.gov Identifier: NCT00211484
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : May 7, 2007
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital

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).

Condition or disease Intervention/treatment Phase
Age-Related Macular Degenerations. Subfoveal Neovascularization. Drug: Anecortave Acetate Phase 2

Manhattan Eye, Ear & Throat Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2003
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. 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 Measures :
  1. mean change in VA(ETDRS), OCT, FA from baseline to 24 months [ Time Frame: 24 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All

Inclusion Criteria:

  1. Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser).
  2. Patients must be 18 years of age or older to receive treatment.
  3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
  4. Visual acuity of 20/800 or better 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 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00211484

United States, New York
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Alcon Research
Principal Investigator: Jason S. Slakter, MD Manhattan Eye, Ear & Throat Hospital

ClinicalTrials.gov Identifier: NCT00211484     History of Changes
Other Study ID Numbers: AA outside standard care
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: May 7, 2007
Last Verified: May 2007

Additional relevant MeSH terms:
Macular Degeneration
Neovascularization, Pathologic
Retinal Degeneration
Retinal Diseases
Eye Diseases
Pathologic Processes
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents