Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

Expanded access is no longer available for this treatment.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00349739
First received: July 6, 2006
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention
Macular Degeneration
Drug: Anecortave Acetate

Study Type: Expanded Access     What is Expanded Access?
Official Title: Clinical Treatment of Patients With Age-Related Macular Degeneration With Anecortave Acetate Sterile Suspension

Resource links provided by NLM:


Further study details as provided by University of Iowa:

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
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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349739

Locations
United States, Iowa
University of Iowa Hospitals and Clinics, Ophthalmology
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Investigators
Principal Investigator: Edwin M Stone, MD, PhD University of Iowa
Study Director: Stephen R. Russell, MD University of Iowa
  More Information

Additional Information:
No publications provided

Responsible Party: Edwin M. Stone, MD, PHD, Professor, Principal investigator, University of Iowa
ClinicalTrials.gov Identifier: NCT00349739     History of Changes
Other Study ID Numbers: UIOWA200101096, AL-3789
Study First Received: July 6, 2006
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Iowa:
age related macular degeneration

Additional relevant MeSH terms:
Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases
Anecortave
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014