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

This study has been terminated.

Sponsors and Collaborators: Manhattan Eye, Ear & Throat Hospital
Alcon Research
Information provided by: Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier: NCT00211406
  Purpose

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.


Condition Intervention Phase
Diabetic Retinopathy
Drug: Anecortave Acetate Sterile Suspension (15 mg)
Phase I

MedlinePlus related topics:   Diabetic Eye Problems    Retinal Disorders   

ChemIDplus related topics:   Anecortave acetate   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211406

Locations
United States, New York
Manhattan Eye, Ear & Throat Hospital    
      New York, New York, United States, 10021

Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Alcon Research

Investigators
Principal Investigator:     Lawrence Yannuzzi, MD     Manhattan Eye, Ear & Throat Hospital    
  More Information


Study ID Numbers:   Diabetic Retinopathy
First Received:   September 13, 2005
Last Updated:   May 6, 2007
ClinicalTrials.gov Identifier:   NCT00211406
Health Authority:   United States: Food and Drug Administration

Study placed in the following topic categories:
Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases
Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 03, 2008




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