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Tracking Information | |||||||||
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First Received Date † | July 18, 2007 | ||||||||
Last Updated Date | February 17, 2009 | ||||||||
Start Date † | August 2007 | ||||||||
Current Primary Outcome Measures † |
Best corrected visual acuity [ Time Frame: one year ] [ Designated as safety issue: No ] | ||||||||
Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00504400 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||||||
Descriptive Information | |||||||||
Brief Title † | Ranibizumab to Treat Type 2 Idiopathic Macular Telangiectasia (RAMA-Trial) | ||||||||
Official Title † | Ranibizumab in Idiopathic Macular Telangiectasia, Type 2. A Prospective Interventional Non-Randomized Study Comparing the Efficacy and Safety of Intravitreal Ranibizumab in Type 2 Idiopathic Macular Telangiectasia. | ||||||||
Brief Summary | The purpose of this study is to investigate if a new drug called ranibizumab is effective to treat a rare bilateral disease of the macula: type 2 idiopathic macular telangiectasia (type 2 IMT). 10 patients will receive monthly injections of the drug into one eye over a period of one year. |
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Detailed Description | Type 2 idiopathic macular telangiectasia (type 2 IMT) is a retinal disease of unknown etiology that commonly presents with a slow decrease in visual acuity, reading difficulties and metamorphopsia in the fifth to seventh decade. Diagnosis is based on fluorescein angiography which typically reveals parafoveal leakage in the late phase and may show telangiectatic capillaries in the early phase. In a subset of patients, a proliferative stage with secondary neovascularizations may develop late in the disease course. In the past, there has been no effective treatment for the disease stages without neovascularization. Recent studies in a limited number of patients with nonproliferative disease have shown promising results after intravitreal injection of bevacizumab, an antagonist targeting vascular endothelial growth factor (VEGF). Bevacizumab resulted in a decrease of parafoveal leakage in fluorescein angiography and a decrease in retinal thickness. An increase in visual acuity was reported in a subset of patients. The RAMA-Trial is initiated in order to investigate the effect of a ranibizumab. The safety and tolerability of this VEGF-antagonist has been extensively studied in large cohorts of patients suffering from age-related macular degeneration. Patients with type 2 IMT will receive monthly injections over a period of one year. The above mentioned outcome measures will be assessed. |
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Study Phase | Phase II | ||||||||
Study Type † | Interventional | ||||||||
Study Design † | Treatment, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||||||
Condition † | Type 2 Idiopathic Macular Telangiectasia | ||||||||
Intervention † | Drug: Intravitreal injection ranibizumab | ||||||||
Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Enrolling by invitation | ||||||||
Enrollment † | 10 | ||||||||
Estimated Completion Date | August 2009 | ||||||||
Estimated Primary Completion Date | July 2009 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | Germany | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00504400 | ||||||||
Responsible Party | University of Bonn, University of Bonn | ||||||||
Secondary IDs †† | EudraCT number 2006-006233-40 | ||||||||
Study Sponsor † | University Hospital, Bonn | ||||||||
Collaborators †† | Novartis | ||||||||
Investigators † |
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Information Provided By | University Hospital, Bonn | ||||||||
Verification Date | February 2009 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |