Treatment of Idiopathic Perifoveal Telangiectasia (IPT) With Open-Label Anecortave Acetate (15mg.).
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.
Manhattan Eye, Ear & Throat Hospital has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
- To investigate the use of anecortave acetate fot treatment of idiopathic perifoveal telangiectasia [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- mean change of VA (ETDRS)from baseline to 24 months [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
|Study Start Date:||March 2002|
|Study Completion Date:||March 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211328
|United States, New York|
|Manhattan Eye, Ear & Throat Hospital|
|New York, New York, United States, 10021|
|Principal Investigator:||Lawrence A. Yannuzzi, MD||Manhattan Eye, Ear & Throat Hospital|