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

Sponsors and Collaborators:	Manhattan Eye, Ear & Throat Hospital Alcon Research
Information provided by:	Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:	NCT00211367

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 II

MedlinePlus related topics: Eye Injuries Retinal Disorders

Drug Information available for: Anecortave acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Inclusion Criteria:

Clinical diagnosis of radiation retinopathy.
Patients must be 18 years of age or older to receive treatment.
Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart.

Exclusion Criteria:

Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
Patients who have undergone intraocular surgery within the last 2 months
Patient participating in any other investigational drug study.
Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
Inability to obtain photographs to document choroidal neovascularization (CNV) (including difficulty with venous access)
Patient with significant liver disease or uremia.
Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
Patient has a history of any medical condition which would preclude scheduled visits or completion of study
Patient has had insertion of scleral buckle in the study eye
Patient has received radiation treatment
Patient is on anticoagulant therapy with the exception of aspirin
Patient is pregnant or nursing.

Contacts and Locations

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

Study ID Numbers:	AA in Rad.Ret.
Study First Received:	September 13, 2005
Last Updated:	June 20, 2007
ClinicalTrials.gov Identifier:	NCT00211367
Health Authority:	United States: Food and Drug Administration

Keywords provided by Manhattan Eye, Ear & Throat Hospital:

Radiation Retinopathy

Study placed in the following topic categories:

Craniocerebral Trauma
Facial Injuries
Facies
Eye Injuries

Wounds and Injuries
Disorders of Environmental Origin
Retinal Diseases

ClinicalTrials.gov processed this record on January 16, 2009