Combination Therapy for Neovascular Age Related Macular Degeneration

NCT ID: NCT00447031

Last Updated: 2010-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-11-30

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.

Detailed Description

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Conditions

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Macular Degeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intravitreal bevacizumab and triamcinolone acetonide

Intervention Type DRUG

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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yonsei University

OTHER

Sponsor Role lead

Principal Investigators

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Hyoung Jun Koh

Role: PRINCIPAL_INVESTIGATOR

YUMC

Locations

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Department of Ophthalmology, Yonsei University College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 17333238 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17290193 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17151484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17186262 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17317397 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17324219 (View on PubMed)

Other Identifiers

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koh02

Identifier Type: -

Identifier Source: org_study_id

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