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

Primary Purpose

Coat's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
anecortave acetate
Sponsored by
Manhattan Eye, Ear & Throat Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coat's Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Manhattan Eye, Ear & Throat Hospital

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
September 13, 2005
Last Updated
October 23, 2012
Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT00211315
Brief Title
Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
March 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2007 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Manhattan Eye, Ear & Throat Hospital
Collaborators
Alcon Research

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coat's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
anecortave acetate
Primary Outcome Measure Information:
Title
to investigate the use of anecortave acetate in coats's disease
Time Frame
24 months
Secondary Outcome Measure Information:
Title
mean change in ETDRS visual acuity , OCT, leakage in FA compared at baseline at month 24.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence A. Yannuzzi, MD
Organizational Affiliation
Manhattan Eye, Ear & Throat Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Manhattan Eye, Ear & Throat Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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