Coat's DiseasePhase 2NCT00211315
Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)
A Phase 2 study testing anecortave acetate in people with Coat's Disease, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coat's Disease
- What is being tested?
- anecortave acetate
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2002to Mar 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Manhattan Eye, Ear & Throat Hospital
New York, New York, 10021
About this study
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.
Read the 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.
- Conditions
- Coat's Disease
- Being tested
- anecortave acetate
- Medical subject headings
- Retinal Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anecortave acetateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
to investigate the use of anecortave acetate in coats's disease
Measured: 24 months
Secondary outcomes (1)
mean change in ETDRS visual acuity , OCT, leakage in FA compared at baseline at month 24.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startMar 2002
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coat's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manhattan Eye, Ear & Throat Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Alcon Research
- Investigators
- Lawrence A. Yannuzzi, MD, Principal investigator, Manhattan Eye, Ear & Throat Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00211315
- Sponsor's protocol ID
- AA in Coat's Disease
- Status last verified
- Oct 2012
- First submitted
- 13 Sep 2005
- Last updated
- 24 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Congenital Telangiectasia (Coat's Disease) With Open-label Anecortave Acetate (15mg.)
- ClinicalTrials.gov ID
- NCT00211315
- Acronym / sponsor ID
- AA in Coat's Disease
- Conditions
- Coat's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Mar 2002
- Study completion
- Mar 2007
- First posted
- 21 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anecortave acetate | Drug | – |
Primary outcome
to investigate the use of anecortave acetate in coats's disease
Time frame: 24 months
1 secondary outcome
mean change in ETDRS visual acuity , OCT, leakage in FA compared at baseline at month 24.
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2012.
Related trials for Coat's Disease
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Retinopathy of Prematurity Both Eyes, Retinal Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence A. Yannuzzi, MD principal investigator
Manhattan Eye, Ear & Throat Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing anecortave acetate in people with Coat's Disease, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to investigate the use of anecortave acetate in coats's disease (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2012.