Skip to main content
OpenTrials
Completed

NCT Number: NCT00211315

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Manhattan Eye, Ear & Throat Hospital

New York, 10021, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

anecortave acetate

Drug

Primary outcomes

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

    Time frame: 24 months

Secondary outcomes

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

    Time frame: 24 months

Sponsors and collaborators

Lead sponsor

Manhattan Eye, Ear & Throat Hospital

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2002
Study completion
2007
First posted
Sep 21, 2005
Registry last updated
Oct 24, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.