Combination Therapy for Neovascular Age Related Macular Degeneration

Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00447031
• Other study ID #: koh02
• Status: Withdrawn
• Phase: N/A
• First received: March 12, 2007
• Last updated: February 5, 2010
• Start date: March 2007
• Est. completion date: November 2007

Study information

• Verified date: March 2009
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Wet Macular Degeneration

Intervention

Drug:
• intravitreal bevacizumab and triamcinolone acetonide

Locations

Country	Name	City	State
Korea, Republic of	Department of Ophthalmology, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (6)

Aisenbrey S, Ziemssen F, Völker 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. Epub 2006 Dec 21. — View Citation

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. — View Citation

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. Epub 2007 Feb 28. — View Citation

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. — View Citation

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. Epub 2006 Dec 8. — View Citation

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. Epub 2007 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence rate
Primary	best corrected visual acuity
Secondary	complication rate