Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.

NCT00211484 | Completed Phase 2

• 1 other identifier: AA outside standard care
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

A compassionate method of treatment is offered to patients where lesions do not meet acceptable criteria for standard therapy. Visudyne (Photodynamic Therapy) and laser photocoagulation treatment (a treatment using heat from a fine point laser beam) have not been found to be effective in treating the lesions these patients have. Anecortave acetate is an experimental drug that is being tested to prevent the growth of blood vessels under the retina in patients with age-related macular degeneration (AMD).

Conditions

Age-Related Macular Degenerations.; Subfoveal Neovascularization.

Outcome Measures

Primary Outcomes (1)

• This study is designed to provide compassionate use of Anecortave Acetate Sterile Suspension of 15mg for a series of five patients where the lesions do not meet acceptable criteria for standard therapy.

  24 months

Secondary Outcomes (1)

• mean change in VA(ETDRS), OCT, FA from baseline to 24 months

  24 months

Interventions

Anecortave Acetate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser).
• Patients must be 18 years of age or older to receive treatment.
• Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart.
• Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart.

You may not qualify if:

• Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
• Patients who have undergone intraocular surgery within last 2 months.
• Patient participating in any other investigational drug study.
• Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication.
• Inability to obtain photographs to document CNV (including difficulty with venous access).
• Patient with significant liver disease or uremia.
• Patient with known adverse reaction to fluorescein and indocyanine green or iodine.
• Patient has a history of any medical condition which would preclude scheduled visits or completion of study.
• Patient has had insertion of scleral buckle in the study eye.
• Patient has received radiation treatment.
• Patient is on anticoagulant therapy with the exception of aspirin.
• Patient is pregnant or nursing.

Sponsors & Collaborators

• Manhattan Eye, Ear & Throat Hospital: lead
• Alcon Research: collaborator

Study Sites (1)

Manhattan Eye, Ear & Throat Hospital

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Interventions

anecortave acetate

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Jason S. Slakter, MD

  Manhattan Eye, Ear & Throat Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Expanded Access: Yes

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: May 1, 2003
• Study Completion: March 1, 2007
• Last Updated: May 7, 2007

Record last verified: 2007-05

Locations

US (1)