Clinical trial NCT00349739: Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate
Official title: Clinical Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate Sterile Suspension
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Macular Degeneration
Keywords: age related macular degeneration
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2006-07-10
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Choroidal neovascularization, mostly occult
* Visual acuity \> 20/40 in study eye

Exclusion Criteria:

* Allergy to fluorescein dye
* Inability to stop warfarin prior to treatment
* Pregnancy
* Other serious ocular diseases or conditions

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics, Ophthalmology
state: Iowa
Study officials:
affiliation: University of Iowa
name: Edwin M Stone, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Iowa
name: Stephen R. Russell, MD
role: STUDY_DIRECTOR
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