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WithdrawnNCT00447031Updated Feb 9, 2010

Combination Therapy for Neovascular Age Related Macular Degeneration

An interventional study of intravitreal bevacizumab and triamcinolone acetonide in Macular Degeneration, sponsored by Yonsei University. Withdrawn at 1 site in Korea, Republic of. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2010-02-09.

Sponsored by Yonsei University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Insufficient patients who met inclusion criteria
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
50 Years and older
Sex
All
01

Study summary

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.

02

Conditions studied

  • Macular Degeneration

Keywords

  • age related macular degeneration
  • intravitreal bevacizumab
  • intravitreal triamcinolone acetonide
  • neovascular age related macular degeneration
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In context

Macular Degeneration

1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.

Browse Macular Degeneration studies →

Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Neovascular ARMD confirmed with 90+ noncontact lens biomicroscopy, fluorescein angiography, ocular coherence tomography

Exclusion criteria

Exclusion Criteria:

  • Intractable systemic hypertension
  • Recent myocardial infarct within 6 months at enrollment
  • Recent cerebrovascular attack within 6 months
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Interventions

  • Drugintravitreal bevacizumab and triamcinolone acetonide
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What researchers measure

Primary outcomes

  1. recurrence rate

  2. best corrected visual acuity

Secondary outcomes

  1. complication rate

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Study locations

1 site
  • Department of Ophthalmology, Yonsei University College of Medicine
    Seoul, 120-752, Korea, Republic of
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References and documents

Publications

  • Costa RA, Jorge R, Calucci D, Melo LA Jr, Cardillo JA, Scott IU. Intravitreal bevacizumab (Avastin) in combination with verteporfin photodynamic therapy for choroidal neovascularization associated with age-related macular degeneration (IBeVe Study). Graefes Arch Clin Exp Ophthalmol. 2007 Sep;245(9):1273-80. doi: 10.1007/s00417-007-0557-x. Epub 2007 Feb 28. PubMed 17333238 ↗
  • Augustin AJ, Puls S, Offermann I. Triple therapy for choroidal neovascularization due to age-related macular degeneration: verteporfin PDT, bevacizumab, and dexamethasone. Retina. 2007 Feb;27(2):133-40. doi: 10.1097/IAE.0b013e3180323de7. PubMed 17290193 ↗
  • Dhalla MS, Shah GK, Blinder KJ, Ryan EH Jr, Mittra RA, Tewari A. Combined photodynamic therapy with verteporfin and intravitreal bevacizumab for choroidal neovascularization in age-related macular degeneration. Retina. 2006 Nov-Dec;26(9):988-93. doi: 10.1097/01.iae.0000247164.70376.91. PubMed 17151484 ↗
  • Aisenbrey S, Ziemssen F, Volker M, Gelisken F, Szurman P, Jaissle G, Grisanti S, Bartz-Schmidt KU. Intravitreal bevacizumab (Avastin) for occult choroidal neovascularization in age-related macular degeneration. Graefes Arch Clin Exp Ophthalmol. 2007 Jul;245(7):941-8. doi: 10.1007/s00417-006-0471-7. Epub 2006 Dec 21. PubMed 17186262 ↗
  • Gomi F, Nishida K, Oshima Y, Sakaguchi H, Sawa M, Tsujikawa M, Tano Y. Intravitreal bevacizumab for idiopathic choroidal neovascularization after previous injection with posterior subtenon triamcinolone. Am J Ophthalmol. 2007 Mar;143(3):507-10. doi: 10.1016/j.ajo.2006.10.050. Epub 2006 Dec 8. PubMed 17317397 ↗
  • Jonas JB, Libondi T, Ihloff AK, Harder B, Kreissig I, Schlichtenbrede F, Sauder G, Spandau UH. Visual acuity change after intravitreal bevacizumab for exudative age-related macular degeneration in relation to subfoveal membrane type. Acta Ophthalmol Scand. 2007 Aug;85(5):563-5. doi: 10.1111/j.1600-0420.2007.00891.x. Epub 2007 Feb 27. PubMed 17324219 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00447031
Lead sponsor
Yonsei University
First posted
Mar 13, 2007
Start date
Mar 2007
Completion
Nov 2007 (estimated)
Last update
Feb 9, 2010

Study contacts

Hyoung Jun Koh
principal investigator · YUMC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2009. You cannot join it, but the record below documents what was studied.

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