Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)

Manhattan Eye, Ear & Throat Hospital

Status and phase: Terminated; Phase 1

Conditions: Diabetic Retinopathy

Treatments: Drug: Anecortave Acetate Sterile Suspension (15 mg)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00211406

Diabetic Retinopathy

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Clinical diagnosis of patients with diabetic retinopathy.
2. Patients must be at least 18 years of age.
3. Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
4. Visual acuity of 20/800 or better in 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 the 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 choroidal neovascularization (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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)