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

This study has been terminated.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211406
First received: September 13, 2005
Last updated: May 6, 2007
Last verified: May 2007
  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 1

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

Resource links provided by NLM:


Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014