Idiopathic Perifoveal TelangiectasiaPhase 2NCT00211328
Treatment of Idiopathic Perifoveal Telangiectasia (IPT) With Open-Label Anecortave Acetate (15mg.).
A Phase 2 study testing anecortave acetate in people with Idiopathic Perifoveal Telangiectasia, run by Manhattan Eye, Ear & Throat Hospital at 1 site in United States.
Trial summary
Idiopathic Perifoveal telangiectasia is a poorly understood disorder that involves the growth of blood vessels around the center of the macula(perifoveal region). These blood vessels may extrend beneath the retina to produce an area of sub-retinal neosvascularization(growth of abnormal blood vessels under the retina… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Idiopathic Perifoveal Telangiectasia
- What is being tested?
- anecortave acetate
- How many people
- 5 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 patients with Idiopathic Perifoveal Telangiectasia(IPT).
- 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.
- 3.Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
- 4.Inability to obtain photographs to document CNV (including difficulty with venous access).
- 5.Patient with significant liver disease or uremia. 6.Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
- 7.Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
- 8.Patient has had insertion of scleral buckle in the study eye. 9.Patient has received radiation treatment 10.Patient is on anticoagulant therapy with the exception of aspirin 11.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
Idiopathic Perifoveal telangiectasia is a poorly understood disorder that involves the growth of blood vessels around the center of the macula(perifoveal region). These blood vessels may extrend beneath the retina to produce an area of sub-retinal neosvascularization(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 is considered as an attempt to control the growth of the abnormal blood vessels.
Read the detailed description
In this open-label pilot study, an initial patient, which presented with IPT and SRN, was treated with promising success and five additional patients were then recruited. So this is a report on six eyes of the first six patients with this disease who presented in our practice. The Food and Drug Administration (FDA) granted our site permission to enroll these patients. While anecortave acetate has not yet been approved by the FDA, it has been used in phase 2/3 trials for the treatment of AMD. An informed consent was obtained from each patient. IRB approval was obtained from Manhattan Eye, Ear, and Throat Hospital.
Patients received a posterior juxtascleral injection of 15 mg of anecortave acetate delivered adjacent to the macula using the specially designed curved cannula by Alcon, Inc. Visual acuity (VA) and intraocular pressure (IOP) were measured on each study visit. Fluorescein angiography was used to complement the standard clinical biomicroscopic examination of the macula at baseline and at 3 months intervals. On the first day post-injection, patients had an additional ophthalmic examination including VA testing, biomicroscopy, and IOP measurement.
A 6-month retreatment interval was established for this study based on laboratory data demonstrating that anecortave acetate administered as a slow-release depot adjacent to the posterior scleral surface provided therapeutic drug levels in the adjacent choroid and retina for up to 6 months (9). If patients were clinically unstable or unimproved six months after enrollment, they were offered thermal laser treatment or photodynamic therapy (PDT) in conjunction with the anecortave acetate injection. Patients who were unstable as early as 3 months after enrollment were offered the option to be treated with either thermal laser or PDT. This did not disqualify them from being eligible for the repeat anecortave acetate injection at month 6.
- Conditions
- Idiopathic Perifoveal Telangiectasia
- Being tested
- anecortave acetate
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 fot treatment of idiopathic perifoveal telangiectasia
Measured: 24 months
Secondary outcomes (1)
mean change of VA (ETDRS)from baseline to 24 months
Measured: 2 years
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 Idiopathic Perifoveal TelangiectasiaStudies 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
- 5 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
- NCT00211328
- Sponsor's protocol ID
- AA in IPT
- Status last verified
- Feb 2009
- First submitted
- 13 Sep 2005
- Last updated
- 4 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Idiopathic Perifoveal Telangiectasia (IPT) With Open-Label Anecortave Acetate (15mg.).
- ClinicalTrials.gov ID
- NCT00211328
- Acronym / sponsor ID
- AA in IPT
- Conditions
- Idiopathic Perifoveal Telangiectasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Manhattan Eye, Ear & Throat HospitalUniversity, hospital or other
- Collaborators
- Alcon Research
- Study start
- Mar 2002
- Study completion
- Mar 2007 (actual)
- 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.
Idiopathic Perifoveal telangiectasia is a poorly understood disorder that involves the growth of blood vessels around the center of the macula(perifoveal region). These blood vessels may extrend beneath the retina to produce an area of sub-retinal neosvascularization(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 is considered as an attempt to control the growth of the abnormal blood vessels.
Detailed description
In this open-label pilot study, an initial patient, which presented with IPT and SRN, was treated with promising success and five additional patients were then recruited. So this is a report on six eyes of the first six patients with this disease who presented in our practice. The Food and Drug Administration (FDA) granted our site permission to enroll these patients. While anecortave acetate has not yet been approved by the FDA, it has been used in phase 2/3 trials for the treatment of AMD. An informed consent was obtained from each patient. IRB approval was obtained from Manhattan Eye, Ear, and Throat Hospital.
Patients received a posterior juxtascleral injection of 15 mg of anecortave acetate delivered adjacent to the macula using the specially designed curved cannula by Alcon, Inc. Visual acuity (VA) and intraocular pressure (IOP) were measured on each study visit. Fluorescein angiography was used to complement the standard clinical biomicroscopic examination of the macula at baseline and at 3 months intervals. On the first day post-injection, patients had an additional ophthalmic examination including VA testing, biomicroscopy, and IOP measurement.
A 6-month retreatment interval was established for this study based on laboratory data demonstrating that anecortave acetate administered as a slow-release depot adjacent to the posterior scleral surface provided therapeutic drug levels in the adjacent choroid and retina for up to 6 months (9). If patients were clinically unstable or unimproved six months after enrollment, they were offered thermal laser treatment or photodynamic therapy (PDT) in conjunction with the anecortave acetate injection. Patients who were unstable as early as 3 months after enrollment were offered the option to be treated with either thermal laser or PDT. This did not disqualify them from being eligible for the repeat anecortave acetate injection at month 6.
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 patients with Idiopathic Perifoveal Telangiectasia(IPT).
- 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 (8 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.
- 3.Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
- 4.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 fot treatment of idiopathic perifoveal telangiectasia
Time frame: 24 months
1 secondary outcome
mean change of VA (ETDRS)from baseline to 24 months
Time frame: 2 years
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 4 Feb 2009.
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 Idiopathic Perifoveal Telangiectasia, 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 8 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 4 Feb 2009. 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 fot treatment of idiopathic perifoveal telangiectasia (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 4 Feb 2009.