Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate
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|ClinicalTrials.gov Identifier: NCT00349739|
Expanded Access Status : No longer available
First Posted : July 10, 2006
Last Update Posted : January 15, 2010
|Condition or disease||Intervention/treatment|
|Macular Degeneration||Drug: Anecortave Acetate|
Choroidal neovascularization (CNV), a complication of age-related macular degeneration (AMD), is the most common cause of profound visual loss in the United States. Laser photocoagulation has been shown to retard visual loss, however only about 20% of patients with CNV are eligible for laser treatment.
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.
|Study Type :||Expanded Access|
|Official Title:||Clinical Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate Sterile Suspension|
|Study Start Date :||January 2003|
|Estimated Study Completion Date :||August 2008|
- Drug: Anecortave Acetate
Dosage: 0.5ml of 30mg/ml(15 mg) or 60mg/ml(30mg) Duration of action: 159-180 daysOther Name: Retaane
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349739
|United States, Iowa|
|University of Iowa Hospitals and Clinics, Ophthalmology|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Edwin M Stone, MD, PhD||University of Iowa|
|Study Director:||Stephen R. Russell, MD||University of Iowa|