Status:
COMPLETED
Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)
Lead Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborating Sponsors:
Alcon Research
Conditions:
Coat's Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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-...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2007
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00211315
Start Date
March 1 2002
End Date
March 1 2007
Last Update
October 24 2012
Active Locations (1)
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1
Manhattan Eye, Ear & Throat Hospital
New York, New York, United States, 10021