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

• Sponsor: Manhattan Eye, Ear & Throat Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00211367
• Collaborator: Alcon Research (Industry)
• Enrollment: 2
• Location: 1
• Duration (Months): 35
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Eye Injuries	Drug: Anecortave Acetate	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: Apr 1, 2004
• Actual Study Completion Date: Mar 1, 2007

Outcome Measures

Primary Outcome Measures

1. to investigate the use of anecortave acetate in radiation retinopathy [24 months]

Secondary Outcome Measures

1. mean change of ETDRS VA from baseline to 24 monthe [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00211367
• Other Study ID Numbers: AA in Rad.Ret.
• First Posted: Sep 21, 2005
• Last Update Posted: Jun 21, 2007
• Last Verified: Jun 1, 2007

• Keywords provided by , ,: Radiation Retinopathy
• Additional relevant MeSH terms: Eye Injuries; Anecortave

Study Results

No Results Posted as of Jun 21, 2007