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Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: Manhattan Eye, Ear & Throat Hospital
Alcon Research
Information provided by: Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier: NCT00211354
  Purpose

Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina. Complications of retinal vein occlusion which threaten vision include neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid "leaking" from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is laser photocoagulation. This treatment has found to have limited use in this type of condition.Anecortave Acetate is being considered as an attempt to control the growth of the abnormal blood vessels.


Condition Intervention Phase
Retinal Vein Occlusion
Drug: Anecortave Acetate
Phase II

Drug Information available for: 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 Retinal Vein Occlusion.
  2. Patients must be 18 years of age or older to receive treatment.
  3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
  4. Visual acuity of 20/800 or better 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 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 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: NCT00211354

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 A. Yannuzzi, MD Manhattan Eye, Ear & Throat Hospital
  More Information

Study ID Numbers: AA in RVO
Study First Received: September 13, 2005
Last Updated: June 20, 2007
ClinicalTrials.gov Identifier: NCT00211354  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Embolism and Thrombosis
Embolism
Eye Diseases
Retinal Vein Occlusion
Vascular Diseases
Venous Thrombosis
Thrombosis
Retinal Diseases

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009