Overview

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

Status:
Completed
Trial end date:
2007-03-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 2
Details
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborator:
Alcon Research
Treatments:
Anecortave
Criteria
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.