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

This study has been completed.
Sponsor:
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211315
First received: September 13, 2005
Last updated: October 23, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Coat's Disease
Drug: anecortave acetate
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Manhattan Eye, Ear & Throat Hospital:

Primary Outcome Measures:
  • to investigate the use of anecortave acetate in coats's disease [ Time Frame: 24 months ]

Secondary Outcome Measures:
  • mean change in ETDRS visual acuity , OCT, leakage in FA compared at baseline at month 24. [ Time Frame: 24 months ]

Enrollment: 4
Study Start Date: March 2002
Estimated Study Completion Date: March 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211315

Locations
United States, New York
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00211315     History of Changes
Other Study ID Numbers: AA in Coat's Disease
Study First Received: September 13, 2005
Last Updated: October 23, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Retinal Telangiectasis
Retinal Diseases
Eye Diseases
Telangiectasis
Vascular Diseases
Cardiovascular Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014