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| Tracking Information | |||||
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| First Received Date ICMJE | September 18, 2006 | ||||
| Last Updated Date | October 2, 2009 | ||||
| Start Date ICMJE | September 2006 | ||||
| Primary Completion Date | September 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters [ Time Frame: 3 months ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
Proportion of subjects with improvement of 15 or more letters of best corrected visual acuity from baseline to 3 months on an Early Treatment Diabetic Retinopathy visual acuity chart measured at 4 meters | ||||
| Change History | Complete list of historical versions of study NCT00378196 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||||
| Brief Title ICMJE | Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial | ||||
| Official Title ICMJE | Ranibizumab in Idiopathic Parafoveal Telangiectasia (RIPT) Trial | ||||
| Brief Summary | This research is being done to look at the effects of an experimental drug, ranibizumab, for the treatment of a condition called "idiopathic parafoveal telangiectasia" or IPT. IPT is caused by swelling in the retina (the light sensitive tissue in the back of the eye) due to leaky blood vessels in this area. Swelling in the retina can lead to blurry vision. |
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| Detailed Description | This study is a randomized, interventional case series. A total of 10 patients, seen in the Retina Division of the Wilmer Eye Institute, will be enrolled. Subjects will be randomized to either 0.3 mg or 0.5 mg intravitreal injections of ranibizumab. Patients with IPT with macular edema documented on optical coherence tomography (OCT) but no choroidal neovascularization will be eligible for this study. Exclusion criteria will include other forms of retinopathy, active intraocular inflammation, history of poor vision due to conditions other than IPT in either eye, and known hypersensitivity to humanized monoclonal antibodies. After obtaining informed consent, the patient will undergo baseline assessment including best-corrected ETDRS visual acuity, ocular examination, color fundus photography, fluorescein angiography, and OCT. If both eyes are eligible, the study participant and investigator will choose which eye to be considered the study eye. The study eye will be assigned at random to receive an IVT dose of ranibizumab (0.3 mg/0.05 ml or 0.5 mg/0.05 ml) at the baseline, 1 month, and 2 month visits. Further monthly injections are at the discretion of the examiner, and may be withheld if there is lack of continued improvement (defined as lack of improvement of at least 5 letters on an eye chart compared with 2 previous consecutive visits or lack of decrease of the retinal center point thickness of at least 50 microns compared with 2 previous consecutive visits) or complete success (defined as visual acuity of 20/20 or better or retinal center point thickness <225 microns). |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind (Subject), Dose Comparison, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Telangiectasia | ||||
| Intervention ICMJE | Drug: Ranibizumab | ||||
| Study Arms / Comparison Groups |
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| Publications * | |||||
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* 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 ICMJE | Completed | ||||
| Enrollment ICMJE | 10 | ||||
| Completion Date | December 2008 | ||||
| Primary Completion Date | September 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 ID ICMJE | NCT00378196 | ||||
| Responsible Party | Neil M. Bressler, MD, The Johns Hopkins University | ||||
| Study ID Numbers ICMJE | NA_00002686 | ||||
| Study Sponsor ICMJE | Johns Hopkins University | ||||
| Collaborators ICMJE | Genentech | ||||
| Investigators ICMJE |
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| Information Provided By | Johns Hopkins University | ||||
| Verification Date | October 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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