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| Tracking Information | |||||||||
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| First Received Date ICMJE | November 22, 2006 | ||||||||
| Last Updated Date | July 29, 2008 | ||||||||
| Start Date ICMJE | November 2006 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE |
To determine the safety and tolerability of 0.5 mg dose of Ranibizumab in the treatment of Macular Edema associated with CRVO | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00403039 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intravitreal Ranibizumab Treatment of Central Retinal Vein Occlusion With Macular Edema | ||||||||
| Official Title ICMJE | Phase I Study of Intravitreally Administered Ranibizumab in 20 Subjects With Macular Edema Associated With CRVO. | ||||||||
| Brief Summary | The purpose of this study is to examine the effects of Lucentis for active Central Retinal Vein Occlusion with Macular Edema |
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| Detailed Description | This is an open-label, Phase I study of intravitreally administered ranibizumab in 20 subjects with macular edema associated with CRVO. Patients will be evaluated at baseline with ophthalmic examination, fluorescein angiography, optical coherence tomography, and color photography. Subjects will receive open-label intravitreal injections of 0.5 mg ranibizumab administered every 28 ± 2 days for a total of 3 injections. Thereafter they are to be evaluated every month until month 12. If the patients have signs of increased intraretinal hemorrhage or a persistence / increase in central macular edema as determined by optical coherence tomography when compared to their last visit, are eligible for re-injection at that monthly visit. |
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| Study Phase | Phase I | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety Study | ||||||||
| Condition ICMJE | Retinal Vein Occlusion | ||||||||
| Intervention ICMJE | Drug: Ranibizumab (Lucentis ) | ||||||||
| Study Arms / Comparison Groups | |||||||||
| 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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 45 | ||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: Pregnancy (positive pregnancy test) or known to be pregnant, also premenopausal women not using adequate contraception. Participation in another simultaneous ocular investigation or trial Patient with uncontrolled hypertension Patient has a condition that, in the opinion of the investigator would preclude participation in the study (i.e. chronic alcoholism, drug abuse) Patient has significant diabetic retinopathy (greater than moderate NPDR) or macular edema associated with diabetic retinopathy Exam or OCT reveals evidence of vitreoretinal interface abnormality that may be contributing to the macular edema Eye that in the investigator has no chance of improvement in visual acuity following resolution of macular edema (i.e subretinal fibrosis or geographic atrophy) Any other additional ocular diseases which could irreversibly compromise the visual acuity of the study eye including amblyopia, anterior ischemic optic neuropathy (AION), age related macular degeneration (AMD), retinal detachment, severe cataracts, etc. Evidence of neovascularization of the iris or retina (presence of ischemic CRVO) History of Grid/Focal laser or Panretinal laser in the study eye History of vitreous surgery in the study eye History of use of intravitreal, peribulbar, or retrobulbar steroids within six months of the study. History of Cataract Surgery within 6 months of enrollment. History of YAG capsulotomy within 2 months of the surgery. Visual acuity <20/400 in the fellow eye Uncontrolled Glaucoma, pressure >30 despite treatment with glaucoma medications. Use of Bevacizumab in either eye within the past 30 days Use of Pegaptinib sodium in either eye within the past 6 weeks Use of Triamcinolone in either eye Have received any other systemic experimental drug within 12 weeks prior to enrollment. Unwilling or unable to follow or comply with all study related procedures. |
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| Gender | Both | ||||||||
| Ages | |||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00403039 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | FVF3851S | ||||||||
| Study Sponsor ICMJE | Vitreous -Retina- Macula Consultants of New York | ||||||||
| Collaborators ICMJE | Genentech | ||||||||
| Investigators ICMJE |
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| Information Provided By | Vitreous -Retina- Macula Consultants of New York | ||||||||
| Verification Date | July 2008 | ||||||||
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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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