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

NCT00211367 | Terminated Phase 2

• 1 other identifier: AA in Rad.Ret.
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Injuries

Keywords

Radiation Retinopathy

Outcome Measures

Primary Outcomes (1)

• to investigate the use of anecortave acetate in radiation retinopathy

  24 months

Secondary Outcomes (1)

• mean change of ETDRS VA from baseline to 24 monthe

  2 years

Interventions

Anecortave Acetate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• Alcon Research: collaborator

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Eye Injuries

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Facial Injuries; Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Eye Diseases; Wounds and Injuries

Study Officials

• Lawrence A. Yannuzzi, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: April 1, 2004
• Study Completion: March 1, 2007
• Last Updated: June 21, 2007

Record last verified: 2007-06

Locations

US (1)