Treatment of Diabetic Retinopathy With Open-Label Anecortave Acetate Sterile Suspension (15 mg)
This study has been terminated.
Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211406
First received: September 13, 2005
Last updated: May 6, 2007
Last verified: May 2007
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Purpose
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 diabetic retinopathy.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Retinopathy |
Drug: Anecortave Acetate Sterile Suspension (15 mg) |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Manhattan Eye, Ear & Throat Hospital:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
Criteria
Inclusion Criteria:
- Clinical diagnosis of patients with diabetic retinopathy.
- Patients must be at least 18 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
Exclusion Criteria:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00211406
Locations
| United States, New York | |
| Manhattan Eye, Ear & Throat Hospital | |
| New York, New York, United States, 10021 | |
Sponsors and Collaborators
Manhattan Eye, Ear & Throat Hospital
Alcon Research
Investigators
| Principal Investigator: | Lawrence Yannuzzi, MD | Manhattan Eye, Ear & Throat Hospital |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00211406 History of Changes |
| Other Study ID Numbers: | Diabetic Retinopathy |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 6, 2007 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetic Retinopathy Retinal Diseases Eye Diseases Diabetic Angiopathies Vascular Diseases |
Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013