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

This study has been terminated.
(poor enrollment)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211367
First Posted: September 21, 2005
Last Update Posted: June 21, 2007
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
Radiation retinopathy is a disease of the retina. It occurs in people who have received or been exposed to radiation near the eyes. The blood vessels are abnormal and may grow which lead to scarring and a loss of central vision. Currently, the treatment for radiation retinopathy is laser photocoagulation. This treatment has been found to have limited use in this type of condition. Compassionate use of anecortave acetate injection is being considered to prevent the growth of the blood vessels under the retina.

Condition Intervention Phase
Eye Injuries 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • to investigate the use of anecortave acetate in radiation retinopathy [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • mean change of ETDRS VA from baseline to 24 monthe [ Time Frame: 2 years ]

Enrollment: 2
Study Start Date: April 2004
Study Completion Date: March 2007
Detailed Description:

Patients will receive an injection of 15 mg of Anecortave acetate behind the eye to be treated ("study eye"). They will be evaluated every six months to determine if their condition is stable or worse. Following the injection of study medication, patients will not be required to come in to see the study physician. The investigator or study staff will call the patients on the day following injection to make sure there were no adverse effects to the injection. Patients will then come in for a Month 1 and a Month 3 follow-up visit. At the Month 3 follow-up visit, if patients are not showing stability or improvement, they may be offered either thermal laser or Photodynamic Therapy. They will remain in the study and remain eligible for a repeat injection of Anecortave Acetate at the Month 6 visit.

Patients will then been seen at Month 6 for a Re-treatment Evaluation Visit. If their condition is stable, they will be offered re-injection with the same study medication they received earlier. If Patients are not showing stability or improvement at the Month 6 visit, they may be offered thermal laser or Photodynamic Therapy in conjunction with the Anecortave Acetate injection.

Patients will then come back again for a Month 1 and a Month 3 visit and an Exit Visit, if necessary. If the patient's condition is worse, patients will be exited from this study and offered standard treatment.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  1. Clinical diagnosis of radiation retinopathy.
  2. Patients must be 18 years of age or older to receive treatment.
  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
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): NCT00211367


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

ClinicalTrials.gov Identifier: NCT00211367     History of Changes
Other Study ID Numbers: AA in Rad.Ret.
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: June 21, 2007
Last Verified: June 2007

Keywords provided by Manhattan Eye, Ear & Throat Hospital:
Radiation Retinopathy

Additional relevant MeSH terms:
Eye Injuries
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Eye Diseases
Wounds and Injuries
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents