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Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)

This study has been withdrawn prior to enrollment.
(No subjects enrolled)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211354
First Posted: September 21, 2005
Last Update Posted: February 4, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
  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 2

Manhattan Eye, Ear & Throat Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.  

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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

Primary Outcome Measures:
  • to investigate the use of anecortave acetate for treatment of retinal vein occlusion [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • mean change of VA (ETDRS) from baseline to 24 months [ Time Frame: 24 months ]

Enrollment: 0
Study Start Date: March 2002
Estimated Study Completion Date: April 2007
Estimated Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: anecortave acetate
anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months
Drug: Anecortave Acetate
ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.
Other Name: retaane

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Joan Daly,RN, LuEsther T. Mertz Retinal Research Center
ClinicalTrials.gov Identifier: NCT00211354     History of Changes
Other Study ID Numbers: AA in RVO
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: February 4, 2009
Last Verified: February 2009

Additional relevant MeSH terms:
Retinal Vein Occlusion
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents