Status:
TERMINATED
Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Alcon Research
Conditions:
Diabetic Retinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control diabetic retinopathy.
Eligibility Criteria
Inclusion
- Clinical diagnosis of patients with diabetic retinopathy.
- Patients must be at least 18 years of age.
- Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
- Visual acuity of 20/800 or better in 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 the 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 choroidal neovascularization (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 :
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00211406
Last Update
May 8 2007
Active Locations (1)
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1
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021