Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

New York, New York 10021


Purpose:

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).


Study summary:

Patients will receive a sub-Tenon injection of 15mg of Anecortave acetate in their study eye with the use of a counter pressure device. Patients will then be followed for up to 24 months. The patients will have the option of extending their participation in the study for an additional 24 months. Statistical analysis will include comparison of patient follow-up visual acuity and angiographic data.


Criteria:

Inclusion Criteria: 1. Clinical diagnosis of patients whose lesions do not meet acceptable criteria for standard of care treatment (PDT or laser). 2. Patients must be 18 years of age or older to receive treatment. 3. Visual acuity of 20/30 to 20/320 Study Eye on the ETDRS visual acuity chart. 4. Visual acuity of 20/800 or better Fellow Eye on the ETDRS visual acuity chart. Exclusion Criteria: 1. Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions. 2. Patients who have undergone intraocular surgery within last 2 months. 3. Patient participating in any other investigational drug study. 4. Use of an investigational drug or treatment related or unrelated to their condition within 30 days prior to receipt of study medication. 5. Inability to obtain photographs to document CNV (including difficulty with venous access). 6. Patient with significant liver disease or uremia. 7. Patient with known adverse reaction to fluorescein and indocyanine green or iodine. 8. Patient has a history of any medical condition which would preclude scheduled visits or completion of study. 9. Patient has had insertion of scleral buckle in the study eye. 10. Patient has received radiation treatment. 11. Patient is on anticoagulant therapy with the exception of aspirin. 12. Patient is pregnant or nursing.


Study is Available At:


Original ID:

AA outside standard care


NCT ID:

NCT00211484


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Manhattan Eye, Ear & Throat Hospital


Oversight Authority:

United States: Food and Drug Administration


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Non-Randomized, Endpoint Classificati


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

5


Enrollment Type:

Actual


Overall Contact Information

Official Name:Jason S. Slakter, MD
Principal Investigator
Manhattan Eye, Ear & Throat Hospital

Study Dates

Start Date:May 2003
Completion Date:March 2007
Completion Type:Actual
Verification Date:May 2007
Last Changed Date:May 4, 2007
First Received Date:September 13, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:mean change in VA(ETDRS), OCT, FA from baseline to 24 months
Time Frame:24 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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.
Time Frame:24 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Anecortave Acetate

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Manhattan Eye, Ear & Throat Hospital
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Alcon Research

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: November 18, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.