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

Diabetic Retinopathy Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00211406
• Other study ID #: Diabetic Retinopathy
• Status: Terminated
• Phase: Phase 1
• First received: September 13, 2005
• Last updated: May 6, 2007

Study information

• Verified date: May 2007
• Source: Manhattan Eye, Ear & Throat Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 0
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Retinal Diseases

Intervention

Drug:
• Anecortave Acetate Sterile Suspension (15 mg)

Locations

Country	Name	City	State
United States	Manhattan Eye, Ear & Throat Hospital	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Manhattan Eye, Ear & Throat Hospital	Alcon Research

Country where clinical trial is conducted

United States,