Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care.
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | May 4, 2007 | ||||
| Start Date ICMJE | May 2003 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00211484 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
mean change in VA(ETDRS), OCT, FA from baseline to 24 months [ Time Frame: 24 months ] | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Treatment of Conditions With Open Label-Anecortave Acetate Sterile Suspension ( 15mg.) Where Lesions do Not Meet Acceptable Criteria for Standard Care. | ||||
| Official Title ICMJE | Not Provided | ||||
| 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). |
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| Detailed Description | 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 2 | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Drug: Anecortave Acetate | ||||
| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 5 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Not Provided | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00211484 | ||||
| Other Study ID Numbers ICMJE | AA outside standard care | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Not Provided | ||||
| Study Sponsor ICMJE | Manhattan Eye, Ear & Throat Hospital | ||||
| Collaborators ICMJE | Alcon Research | ||||
| Investigators ICMJE |
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| Information Provided By | Manhattan Eye, Ear & Throat Hospital | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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