Status:
COMPLETED
Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Alcon Research
Conditions:
Age-Related Macular Degenerations.
Subfoveal Neovascularization.
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 t...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT00211484
Start Date
May 1 2003
End Date
March 1 2007
Last Update
May 7 2007
Active Locations (1)
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1
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021