Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate
Summary
The purpose of this study is to evaluate whether anecortave acetate can slow or stop the progression of age-related macular degeneration in patients who do not qualify for other studies and have no other treatment options.
Description
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 Design
N/A
Conditions
Macular Degeneration
Intervention
Anecortave Acetate
Location
University of Iowa Hospitals and Clinics, Ophthalmology
Iowa City
Iowa
United States
52242
Status
No longer available
Source
University of Iowa
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00349739
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:43:36-0400
Clinical Trials
To demonstrate that anecortave acetate is superior to placebo in maintenance of visual acuity at the 12- and 24-month visits.
Anecortave Acetate in Patients With Exudative Age-related Macular Degeneration (AMD)
In this study patients will receive a posterior juxtascleral administration of anecortave acetate for depot suspension 15 mg every three months versus 15 mg every six months versus 30 mg e...
Treatment of Age-Related Macular Degeneration With Anecortave Acetate
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control classic neovascularization f...
The purpose of the study was to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels ...
The purpose of this study is to evaluate the safety of combining juxtasclerally administered anecortave acetate 15 mg with triamcinolone acetate 4 mg administered intravitreally following ...
PubMed Articles
To compare the areas of choriocapillaris (CC) nonperfusion and macular atrophy (MA) in treated exudative age-related macular degeneration.
Appointment Compliance in Patients With Diabetic Macular Edema and Exudative Macular Degeneration.
The purpose of this study is to compare cancellation and no-show rates in patients with diabetic macular edema (DME) and exudative macular degeneration (wet AMD).
To measure visual acuity and metamorphopsia in patients with age-related macular degeneration (AMD) and to explore their relationship with macular lesions.
Epilutein for Early-Stage Age-Related Macular Degeneration: A Randomized and Prospective Study.
The hypothesis that oral supplementation of the epilutein/lutein combination could augment the macular pigment optical density (MPOD) in patients with age-related macular degeneration (AMD) was tested...
Our purpose was to evaluate the relationship between subfoveal choroidal thickness (SCT) and development of macular atrophy (MA) in eyes with age-related macular degeneration (AMD).
Medical and Biotech [MESH] Definitions
Geographic Atrophy
A form of MACULAR DEGENERATION also known as dry macular degeneration marked by occurrence of a well-defined progressive lesion or atrophy in the central part of the RETINA called the MACULA LUTEA. It is distinguishable from WET MACULAR DEGENERATION in that the latter involves neovascular exudates.
Retinal Degeneration
A retrogressive pathological change in the retina, focal or generalized, caused by genetic defects, inflammation, trauma, vascular disease, or aging. Degeneration affecting predominantly the macula lutea of the retina is MACULAR DEGENERATION. (Newell, Ophthalmology: Principles and Concepts, 7th ed, p304)
Vitreoretinal Surgery
Specialized ophthalmic technique used in the surgical repair and or treatment of disorders that include retinal tears or detachment; MACULAR HOLES; hereditary retinal disease; AIDS-related retinal infections; ocular tumors; MACULAR DEGENERATION; DIABETIC RETINOPATHY; and UVEITIS.
Wet Macular Degeneration
A form of RETINAL DEGENERATION in which abnormal CHOROIDAL NEOVASCULARIZATION occurs under the RETINA and MACULA LUTEA, causing bleeding and leaking of fluid. This leads to bulging and or lifting of the macula and the distortion or destruction of central vision.
Macular Degeneration
Degenerative changes in the RETINA usually of older adults which results in a loss of vision in the center of the visual field (the MACULA LUTEA) because of damage to the retina. It occurs in dry and wet forms.
