Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)

NCT ID: NCT00211315

Last Updated: 2012-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2007-03-31

Brief Summary

Congenital Telangiectasia or Coat's disease is an uncommon disorder that involves the growth of blood vessels of the macula. These blood vessels msy extend beneth the retina to produce an area of sub-retinal neovascularization(growth of abnormal blood vessels under the retina which "leak" fluid, causing reduction in vision). Limited forms of treatment are available in managing the neovascularization and its consequences. Anecortave Acetate injection will be considered as an attempt to control the growth of the abnormal blood vessels.

Detailed Description

After evaluation, the patient will receive an injection of anecortave acetate (15mg) juxtascleral with a special cannula in the study eye. the patient will be contacted via phone on the day following the injection. If problem arises patient has to come back to see the study doctor. if patient is stable, a 3 month follow-up visit will be st-up.if the patient does not show improvement, the patient may be offered either thermal laser or PDT. If patient is stable, on the month 6 visit ,the patient will again receive another injection of anecortave acetate. The succeding follow-up schedule will be followed for a total of 24 months.

Conditions

Coat's Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

anecortave acetate

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Clinical diagnosis of congenital Telangiectasia (Coat's Disease).

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alcon Research

INDUSTRY

Sponsor Role: collaborator

Manhattan Eye, Ear & Throat Hospital

OTHER

Sponsor Role: lead

Principal Investigators

Lawrence A. Yannuzzi, MD

Role: PRINCIPAL_INVESTIGATOR

Manhattan Eye, Ear & Throat Hospital

Locations

Manhattan Eye, Ear & Throat Hospital

New York, New York, United States

Countries

United States

Other Identifiers

AA in Coat's Disease

Identifier Type: -

Identifier Source: org_study_id