Combination Therapy for Neovascular Age Related Macular Degeneration
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Purpose
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 |
|---|---|
|
Macular Degeneration |
Drug: intravitreal bevacizumab and triamcinolone acetonide |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration |
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Neovascular ARMD confirmed with 90+ noncontact lens biomicroscopy, fluorescein angiography, ocular coherence tomography
Exclusion Criteria:
- Intractable systemic hypertension
- Recent myocardial infarct within 6 months at enrollment
- Recent cerebrovascular attack within 6 months
Contacts and Locations| Korea, Republic of | |
| Department of Ophthalmology, Yonsei University College of Medicine | |
| Seoul, Korea, Republic of, 120-752 | |
| Principal Investigator: | Hyoung Jun Koh | YUMC |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00447031 History of Changes |
| Other Study ID Numbers: | koh02 |
| Study First Received: | March 12, 2007 |
| Last Updated: | February 5, 2010 |
| Health Authority: | South Korea: Institutional Review Board |
Keywords provided by Yonsei University:
|
age related macular degeneration intravitreal bevacizumab intravitreal triamcinolone acetonide neovascular age related macular degeneration |
Additional relevant MeSH terms:
|
Macular Degeneration Wet Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone hexacetonide Triamcinolone Triamcinolone Acetonide Triamcinolone diacetate Bevacizumab Anti-Inflammatory Agents Therapeutic Uses Pharmacologic Actions |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Growth Inhibitors Antineoplastic Agents |
ClinicalTrials.gov processed this record on May 19, 2013