Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV)
This study has been completed.
Sponsor:
Reza Dana, MD
Information provided by (Responsible Party):
Reza Dana, MD, Massachusetts Eye & Ear Infirmary
ClinicalTrials.gov Identifier:
NCT00681889
First received: May 19, 2008
Last updated: October 10, 2012
Last verified: October 2012
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| Tracking Information | |||||
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| First Received Date ICMJE | May 19, 2008 | ||||
| Last Updated Date | October 10, 2012 | ||||
| Start Date ICMJE | April 2008 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00681889 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV) | ||||
| Official Title ICMJE | Effectiveness and Safety of Topical Ranibizumab for Treatment of Corneal Neovascularization (NV) | ||||
| Brief Summary | The purpose of this study is to determine the effectiveness and safety of ranibizumab (Lucentis) in treatment of corneal neovascularization. |
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| Detailed Description | This is an open label, single site, uncontrolled, single group assignment, safety/efficacy, Phase I study of topical administered ranibizumab in subjects with corneal neovascularization. Ten eyes of patients with corneal neovascularization will be recruited. Patients with superficial or deep corneal neovascularization that extends farther than 2 mm from the limbus will be considered. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 | ||||
| Study Design ICMJE | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE | Corneal Neovascularization | ||||
| Intervention ICMJE | Drug: Ranibizumab
10 Patients will receive treatment (Ranibizumab)
Other Name: Lucentis |
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| Study Arm (s) | Experimental: Treatment Arm
10 Patients will receive treatment (Ranibizumab)
Intervention: Drug: Ranibizumab |
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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 | Completed | ||||
| Enrollment ICMJE | 9 | ||||
| Completion Date | September 2010 | ||||
| Primary Completion Date | September 2009 (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 | NCT00681889 | ||||
| Other Study ID Numbers ICMJE | 07-11-069, 07-11-069 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Reza Dana, MD, Massachusetts Eye & Ear Infirmary | ||||
| Study Sponsor ICMJE | Reza Dana, MD | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Massachusetts Eye and Ear Infirmary | ||||
| Verification Date | October 2012 | ||||
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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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