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Sponsors and Collaborators: |
California Retina Consultants Genentech |
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Information provided by: | California Retina Consultants |
ClinicalTrials.gov Identifier: | NCT00406796 |
The purpose of this study is to determine whether ranibizumab will be effective in reducing if not eliminating the macular edema associated with the disease, central retinal vein occlusion (CRVO).
Condition | Intervention | Phase |
---|---|---|
Central Retinal Vein Occlusion |
Drug: Ranibizumab |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Crossover Assignment, Safety/Efficacy Study |
Official Title: | Phase 1 Study of Intravitreal Ranibizumab (rhuFab V2) in the Treatment of Macular Edema Associated With Perfused Central Retinal Venous Occlusive Disease (CRVO) |
Estimated Enrollment: | 20 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | September 2008 |
Arms | Assigned Interventions |
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1: Active Comparator
0.5mg Ranibizumab
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Drug: Ranibizumab
0.3mg or 0.5mg dose of Ranibizumab 0.05ml administered intravitreally
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2: Active Comparator
0.3mg Ranibizumab
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Drug: Ranibizumab
0.3mg or 0.5mg dose of Ranibizumab 0.05ml administered intravitreally
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Retinal Venous Occlusive disease is the second only to diabetic retinopathy as a major cause of blindness associated with retinal vascular disease. Macular edema is a major cause of vision loss in patients presenting with central abd hemi vein occlusions. Currently, there is no proven treatment to address macular edema in these patients. In the past laser photocoagulation has been used, but was found to offer no visual benefits over the natural history in the treatment of macular edema associated with CRVO. Investigators have demonstrated in case reports that intravitreal triamcinolone (Kenalog) may result in the reduction in macular edema, leading to visual improvement in some patients with CRVO. Triamcinolone is relatively well tolerated in many patients, but its use is associated with significant risk of elevated intraocular pressure, cataract, and intraocular infection.
Ranibizumab (rhuFab V2, an anti-VEGF agent, is a potent inhibitor of vascular permeability, with the potential to reduce retinal vascular leakage and diminish macular edema. In addition, as an anti-VEGF agent, it may also inhibit neovascularization of the iris, a frequent complication of ischemic central retinal vein occlusion. Ranibizumab use as an intravitreal agent does carry the risk of intraocular infection but probably carries very low risk of glaucoma or cataract formation, making it a potentially safer pharmacologic treatment for CRVO associated macular edema as compared to triamcinolone.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
California Retina Consultants | |
Santa Barbara, California, United States, 93103 | |
California Retina Consultants | |
Bakersfield, California, United States, 93309 | |
California Retina Consultants | |
Oxnard, California, United States, 93030 |
Principal Investigator: | Dante J Pieramici, M.D. | California Retina Consultants |
Responsible Party: | California Retina Consultants and Research Foundation ( Dante J Pieramici ) |
Study ID Numbers: | FVF3565s |
Study First Received: | November 29, 2006 |
Last Updated: | December 12, 2007 |
ClinicalTrials.gov Identifier: | NCT00406796 |
Health Authority: | United States: Institutional Review Board |
Macular Edema Embolism and Thrombosis Embolism Eye Diseases Retinal Vein Occlusion |
Vascular Diseases Edema Venous Thrombosis Thrombosis Retinal Diseases |
Cardiovascular Diseases |