Treatment of Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.)
This study has been withdrawn prior to enrollment.
(No subjects enrolled)
Sponsor:
Manhattan Eye, Ear & Throat Hospital
Collaborator:
Alcon Research
Information provided by:
Manhattan Eye, Ear & Throat Hospital
ClinicalTrials.gov Identifier:
NCT00211354
First received: September 13, 2005
Last updated: February 3, 2009
Last verified: February 2009
| Tracking Information | |||||
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| First Received Date ICMJE | September 13, 2005 | ||||
| Last Updated Date | February 3, 2009 | ||||
| Start Date ICMJE | March 2002 | ||||
| Estimated Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
to investigate the use of anecortave acetate for treatment of retinal vein occlusion [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00211354 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
mean change of VA (ETDRS) from baseline to 24 months [ Time Frame: 24 months ] [ Designated as safety issue: Yes ] | ||||
| 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 Retinal Vein Occlusion (RVO) With Open-Label Anecortave Acetate (15mg.) | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | Retinal Vein Occlusion is a blockage of the blood vessels that drain out of the retina. Complications of retinal vein occlusion which threaten vision include neovascularization(growth of new blood vessels)and macular edema ( accumulation of fluid "leaking" from abnormal blood vessels). Currently, the treatment of retinal vein occlusion is laser photocoagulation. This treatment has found to have limited use in this type of condition.Anecortave Acetate is being considered as an attempt to control the growth of the abnormal blood vessels. |
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| Detailed Description | Not Provided | ||||
| 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 | Retinal Vein Occlusion | ||||
| Intervention ICMJE | Drug: Anecortave Acetate
ancortave acetate 15 mg. juxtascleral injection every 6 months for 24 months.
Other Name: retaane |
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| Study Arm (s) | Experimental: anecortave acetate
anecortave acetate 15 mg. juxtascleral injection every 6 months for 24 months
Intervention: Drug: Anecortave Acetate |
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| 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 | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | April 2007 | ||||
| Estimated Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00211354 | ||||
| Other Study ID Numbers ICMJE | AA in RVO | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Joan Daly,RN, LuEsther T. Mertz Retinal Research Center | ||||
| 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 | February 2009 | ||||
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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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