Combination Therapy for Neovascular Age Related Macular Degeneration

NCT00447031 | Withdrawn

• 1 other identifier: koh02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Degeneration

Keywords

age related macular degeneration; intravitreal bevacizumab; intravitreal triamcinolone acetonide; neovascular age related macular degeneration

Outcome Measures

Primary Outcomes (2)

• recurrence rate

• best corrected visual acuity

Secondary Outcomes (1)

• complication rate

Interventions

intravitreal bevacizumab and triamcinolone acetonide DRUG

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Department of Ophthalmology, Yonsei University College of Medicine

Seoul, 120-752, South Korea

Location

Related Publications (6)

• 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.

  PMID: 17333238 BACKGROUND

• 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.

  PMID: 17290193 BACKGROUND

• 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.

  PMID: 17151484 BACKGROUND

• 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.

  PMID: 17186262 BACKGROUND

• 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.

  PMID: 17317397 BACKGROUND

• 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.

  PMID: 17324219 BACKGROUND

MeSH Terms

Conditions

Macular Degeneration

Interventions

Triamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Hyoung Jun Koh

  YUMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 12, 2007
• First Posted: March 13, 2007
• Study Start: March 1, 2007
• Study Completion: November 1, 2007
• Last Updated: February 9, 2010

Record last verified: 2009-03

Locations

KR (1)