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Combination Therapy for Neovascular Age Related Macular Degeneration

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ClinicalTrials.gov Identifier: NCT00447031
Recruitment Status : Withdrawn (Insufficient patients who met inclusion criteria)
First Posted : March 13, 2007
Last Update Posted : February 9, 2010
Sponsor:
Information provided by:
Yonsei University

March 12, 2007
March 13, 2007
February 9, 2010
March 2007
Not Provided
  • recurrence rate
  • best corrected visual acuity
Same as current
Complete list of historical versions of study NCT00447031 on ClinicalTrials.gov Archive Site
complication rate
Same as current
Not Provided
Not Provided
 
Combination Therapy for Neovascular Age Related Macular Degeneration
Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration

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.

Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Macular Degeneration
Drug: intravitreal bevacizumab and triamcinolone acetonide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
50
November 2007
Not Provided

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00447031
koh02
No
Not Provided
Not Provided
Not Provided
Yonsei University
Not Provided
Principal Investigator: Hyoung Jun Koh YUMC
Yonsei University
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP