Treatment of Age-Related Macular Degeneration With Anecortave Acetate
This study has been completed.
Information provided by (Responsible Party):
Joan, Manhattan Eye, Ear & Throat Hospital
First received: September 13, 2005
Last updated: October 24, 2012
Last verified: October 2012
The purpose of this study is to provide compassionate use of anecortave acetate sterile suspension of 15 mg for a series of five patients as a means to control classic neovascularization following failure of treatment with photodynamic therapy using Visudyne.
Drug: Anecortave Acetate Sterile Suspension (15 mg)
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Treatment of Age-Related Macular Degeneration With Open-label Anecortave Acetate Sterile Suspension (15mg) Following Failed Treatment With Photodynamic Therapy With Visudyne
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||September 2007 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||50 Years and older
|Genders Eligible for Study:
- Clinical diagnosis of patients that previously had a failure of treatment with photodynamic therapy using Visudyne.
- Patients must be at least 50 years of age.
- Visual acuity of 20/30 to 20/320 in study eye on the Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity chart
- Visual acuity of 20/800 or better in fellow eye on the ETDRS visual acuity chart
- Patient with significantly compromised visual acuity in the study eye due to concomitant ocular conditions.
- Patients who have undergone intraocular surgery within the 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 choroidal neovascularization (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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211458
|Manhattan Eye, Ear & Throat Hospital
|New York, New York, United States, 10021 |
Manhattan Eye, Ear & Throat Hospital
||Jason S Slakter, MD
||Manhattan Eye, Ear & Throat Hospital
No publications provided
||Joan, Jason Slakter, M.D., Manhattan Eye, Ear & Throat Hospital
History of Changes
|Other Study ID Numbers:
||Failed PDT treated with AA
|Study First Received:
||September 13, 2005
||October 24, 2012
||United States: Food and Drug Administration
Keywords provided by Manhattan Eye, Ear & Throat Hospital:
Age-Related Macular Degeneration
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 17, 2013