COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00349739
Expanded Access Status : No longer available
First Posted : July 10, 2006
Last Update Posted : January 15, 2010
Information provided by:
University of Iowa

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.

Condition or disease Intervention/treatment
Macular Degeneration Drug: Anecortave Acetate

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.

Layout table for study information
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

Intervention Details:
  • Drug: Anecortave Acetate
    Dosage: 0.5ml of 30mg/ml(15 mg) or 60mg/ml(30mg) Duration of action: 159-180 days
    Other Name: Retaane

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00349739

Layout table for location information
United States, Iowa
University of Iowa Hospitals and Clinics, Ophthalmology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Layout table for investigator information
Principal Investigator: Edwin M Stone, MD, PhD University of Iowa
Study Director: Stephen R. Russell, MD University of Iowa

Additional Information:
Layout table for additonal information
Responsible Party: Edwin M. Stone, MD, PHD, Professor, Principal investigator, University of Iowa Identifier: NCT00349739    
Other Study ID Numbers: UIOWA200101096
First Posted: July 10, 2006    Key Record Dates
Last Update Posted: January 15, 2010
Last Verified: January 2010
Keywords provided by University of Iowa:
age related macular degeneration
Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents