- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211315
Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)
October 23, 2012 updated by: Manhattan Eye, Ear & Throat Hospital
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
4
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Manhattan Eye, Ear & Throat Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: NONE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to investigate the use of anecortave acetate in coats's disease
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change in ETDRS visual acuity , OCT, leakage in FA compared at baseline at month 24.
Time Frame: 24 months
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2002
Study Completion
March 1, 2007
Study Registration Dates
First Submitted
September 13, 2005
First Submitted That Met QC Criteria
September 13, 2005
First Posted (ESTIMATE)
September 21, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
October 24, 2012
Last Update Submitted That Met QC Criteria
October 23, 2012
Last Verified
October 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA in Coat's Disease
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Coat's Disease
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Cognito Therapeutics, Inc.RecruitingCognitive Impairment | Dementia | Alzheimer Disease | Mild Cognitive Impairment | Cognitive Decline | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | MCI | Dementia Alzheimers | Mild Dementia | Dementia of Alzheimer Type | Cognitive Impairment, Mild | Alzheimer Disease 1 | Dementia, Mild | Alzheimer... and other conditionsUnited States
-
Abbott Medical DevicesCompletedCoronary Artery Disease | Coronary Heart Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Arterial Occlusive DiseaseUnited States
-
Academisch Medisch Centrum - Universiteit van Amsterdam...CelltrionRecruitingBowel Disease | Inflammatory Disease | Disease CrohnNetherlands
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Eye Hospital Pristina KosovoEnrolling by invitationProgressive Disease of CorneaeKosovo
-
Helix, IncMedical University of South Carolina; HealthPartners Institute; WellSpan Health; St. Luke's Hospital and Health Network, Pennsylvania and other collaboratorsRecruiting
-
Aveiro UniversityPrograma Operacional Inclusão Social e Emprego (POISE); Programa Operacional... and other collaboratorsCompletedLung Diseases | Chronic Obstructive Pulmonary Disease | Pulmonary Disease | Interstitial Lung Disease | Chronic Respiratory DiseasePortugal
-
Medtronic - MITGCompletedInflammatory Bowel Disease, Crohn DiseaseIsrael
-
Cynata Therapeutics LimitedRecruitingGraft Versus Host Disease, AcuteUnited States, Australia, Turkey
Clinical Trials on anecortave acetate
-
Alcon ResearchCompleted
-
Alcon ResearchCompletedMacular DegenerationUnited States
-
Alcon ResearchTerminatedOcular Hypertension | Open-Angle GlaucomaUnited States
-
Alcon ResearchCompletedOpen-angle Glaucoma | Oular HypertensionUnited States
-
Alcon ResearchCompletedOpen-angle Glaucoma
-
Alcon ResearchCompletedEye DiseasesSpain, United States, Hungary, Brazil, Italy, Netherlands, Puerto Rico, United Kingdom
-
Cornea Research Foundation of AmericaTerminatedIntraocular Pressure | TransplantUnited States
-
Alcon ResearchCompletedOpen-angle GlaucomaUnited States