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Sponsored by: |
Yonsei University |
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Information provided by: | Yonsei University |
ClinicalTrials.gov Identifier: | NCT00447031 |
Exudative age related macular degeneration (ARMD) is most common cause of blindness in old population. It is clear that no single therapy addresses the multifactorial pathogenesis of the disease. Recently, studies of intravitreal anti-VEGF therapies such as pegaptanib and bevacizumab have shown the beneficial effect in visual acuity in the treatment of neovascular ARMD. However, the problem with these intravitreal injections is that therapy must be frequently administered for a prolonged but unknown period of time to maintain the benefit. Prolonged, frequent injections may be associated with additional safety risk,lack of convenience and high treatment cost.
Intravitreal steroid injection with anti-inflammatory properties limits any further VEGF upregulation initiated by the inflammation which has been known as one of the pathogenesis and causes of recurrence after the treatment of the neovascular ARMD.
The researchers hypothesize that the combined treatment of intravitreal bevacizumab and triamcinolone acetonide may decrease the recurrence rate after the treatment and obviate the frequent intravitreal injections in the treatment of neovascular ARMD.
In this study, the researchers will compare the recurrence rate of combined treatment of intravitreal bevacizumab and triamcinolone acetonide versus intravitreal bevacizumab alone in the treatment of neovascular ARMD.
Condition | Intervention |
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Macular Degeneration |
Drug: intravitreal bevacizumab and triamcinolone acetonide |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration |
Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Hyoung Jun Koh | 82-2-2228-3570 | hjkoh@yumc.yonsei.ac.kr |
Korea, Republic of | |
Department of Ophthalmology, Yonsei University College of Medicine | Recruiting |
Seoul, Korea, Republic of, 120-752 | |
Principal Investigator: Hyoung Jun Koh |
Principal Investigator: | Hyoung Jun Koh | YUMC |
Study ID Numbers: | koh02 |
Study First Received: | March 12, 2007 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00447031 |
Health Authority: | South Korea: Institutional Review Board |
age related macular degeneration intravitreal bevacizumab intravitreal triamcinolone acetonide neovascular age related macular degeneration |
Triamcinolone Acetonide Eye Diseases Triamcinolone Retinal Degeneration Macular Degeneration |
Triamcinolone diacetate Bevacizumab Retinal Diseases Triamcinolone hexacetonide Retinal degeneration |
Anti-Inflammatory Agents Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Growth Substances Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Enzyme Inhibitors |
Glucocorticoids Hormones Immunosuppressive Agents Angiogenesis Inhibitors Pharmacologic Actions Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents |