Combination Therapy for Neovascular Age Related Macular Degeneration

Study Overview
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Brief Summary
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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.

Official Title
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Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration

Conditions
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Macular Degeneration

Intervention / Treatment
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* Drug: intravitreal bevacizumab and triamcinolone acetonide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: intravitreal bevacizumab and triamcinolone acetonide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recurrence rate |  |  | 
| best corrected visual acuity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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age related macular degeneration, intravitreal bevacizumab, intravitreal triamcinolone acetonide, neovascular age related macular degeneration