- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00211328
Treatment of Idiopathic Perifoveal Telangiectasia (IPT) With Open-Label Anecortave Acetate (15mg.).
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10021
- Manhattan Eye, Ear & Throat Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 .
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.
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To investigate the use of anecortave acetate fot treatment of idiopathic perifoveal telangiectasia
Time Frame: 24 months
|
24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
mean change of VA (ETDRS)from baseline to 24 months
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AA in IPT
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 Idiopathic Perifoveal Telangiectasia
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University Hospital, BonnNovartisCompletedType 2 Idiopathic Macular TelangiectasiaGermany
-
Neurotech PharmaceuticalsThe Lowy Medical Research Institute LimitedCompletedIdiopathic Juxtafoveal TelangiectasiaUnited States
-
Paul S. BernsteinCompletedIdiopathic Juxtafoveal TelangiectasiaUnited States
-
ThromboGenicsCompletedRetinal Telangiectasis | Idiopathic Juxtafoveal Retinal TelangiectasiaFrance, Switzerland
-
The Cleveland ClinicCompletedHereditary Hemorrhagic Telangiectasia | Idiopathic Vascular EctasiaUnited States
-
The Lowy Medical Research Institute LimitedActive, not recruiting
-
Neurotech PharmaceuticalsCompletedMacular TelangiectasiaUnited States, Australia
-
Centre Hospitalier Universitaire DijonRecruitingMacular TelangiectasiaFrance
-
National Eye Institute (NEI)CompletedMacular TelangiectasiaUnited States
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The Lowy Medical Research Institute LimitedActive, not recruitingMacular Telangiectasia Type 2United States, United Kingdom
Clinical Trials on anecortave acetate
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Alcon ResearchCompleted
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Alcon ResearchCompletedMacular DegenerationUnited States
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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