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Combination Therapy for Neovascular Age Related Macular Degeneration

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Yonsei University

Status

Withdrawn

Conditions

Macular Degeneration

Treatments

Drug: intravitreal bevacizumab and triamcinolone acetonide

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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