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

NCT00211315 | Completed Phase 2

• 1 other identifier: AA in Coat's Disease
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Coat's Disease

Outcome Measures

Primary Outcomes (1)

• to investigate the use of anecortave acetate in coats's disease

  24 months

Secondary Outcomes (1)

• mean change in ETDRS visual acuity , OCT, leakage in FA compared at baseline at month 24.

  24 months

Interventions

anecortave acetate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of congenital Telangiectasia (Coat's Disease).
• Patients must be 18 years of age or older to receive treatment.
• Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
• Visual acuity of 20/800 or better 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 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 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

Retinal Telangiectasis

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Telangiectasis; Vascular Diseases; Cardiovascular Diseases

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

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: March 1, 2002
• Study Completion: March 1, 2007
• Last Updated: October 24, 2012

Record last verified: 2012-10

Locations

US (1)