Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate
NCT ID: NCT00349739
Last Updated: 2010-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NO_LONGER_AVAILABLE
EXPANDED_ACCESS
2003-01-31
2008-08-31
Brief Summary
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Detailed Description
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Conventional laser photocoagulation of CNV requires laser intensities adequate to coagulate proteins in the target tissue. Due to the proximity of CNV to the center of vision (fovea), the intensity of laser irradiation necessary, and the heat conduction in the ocular tissues, collateral tissue damage often results which further compromises vision. Recently, a new class of compounds (angiostatic steroids) have been found to inhibit the formation of new blood vessels (i.e. neovascularization) in the eye. One new angiostatic steroid, anecortave acetate (AL-3789), may represent a breakthrough in the therapy of ocular neovascular diseases such as AMD and diabetic retinopathy. Anecortave acetate suppresses the formation of new blood vessels in a variety of models of neovascularization. Unlike some of the angiostatic steroids, anecortave acetate appears to be lacking in the pharmacological activities typical of the steroid family (i.e. glucocorticoid, anti-inflammatory, cardiovascular, neurologic, diuretic, etc.) Additionally, anecortave acetate has been shown to arrest lipopolysaccharide (LPS) and basic fibroblast growth factors (bFGH) induced corneal neovascularization, to attenuate oxygen-induced retinopathy and to inhibit the growth of a highly vascularized intraocular tumor.
The purpose of this study is to treat a small number of patients who would not normally qualify for the other anecortave acetate studies. These patients who are not eligible for the other anecortave acetate studies have no other treatment options and will likely experience a poor visual outcome as a result of their AMD. These patients are excluded from other studies because of "occult" neovascularization and visual acuity worse than 20/40. Sub-Tenon's injection of either 15 mg or 30 mg of anecortave acetate will be administered at the University of Iowa. The patients will be followed for a minimum of 24 months.
Conditions
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Interventions
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Anecortave Acetate
Dosage: 0.5ml of 30mg/ml(15 mg) or 60mg/ml(30mg) Duration of action: 159-180 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Visual acuity \> 20/40 in study eye
Exclusion Criteria
* Inability to stop warfarin prior to treatment
* Pregnancy
* Other serious ocular diseases or conditions
55 Years
ALL
No
Sponsors
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University of Iowa
OTHER
Responsible Party
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University of Iowa
Principal Investigators
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Edwin M Stone, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa
Stephen R. Russell, MD
Role: STUDY_DIRECTOR
University of Iowa
Locations
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University of Iowa Hospitals and Clinics, Ophthalmology
Iowa City, Iowa, United States
Countries
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Related Links
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Laboratory Website
Other Identifiers
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AL-3789
Identifier Type: -
Identifier Source: secondary_id
UIOWA200101096
Identifier Type: -
Identifier Source: org_study_id
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