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Combination Therapy for Neovascular Age Related Macular Degeneration
This study is currently recruiting participants.
Verified by Yonsei University, January 2008
Sponsored by: Yonsei University
Information provided by: Yonsei University
ClinicalTrials.gov Identifier: NCT00447031
  Purpose

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.


Condition Intervention
Macular Degeneration
Drug: intravitreal bevacizumab and triamcinolone acetonide

Genetics Home Reference related topics: X-linked juvenile retinoschisis
MedlinePlus related topics: Macular Degeneration
Drug Information available for: Bevacizumab Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration

Further study details as provided by Yonsei University:

Primary Outcome Measures:
  • recurrence rate
  • best corrected visual acuity

Secondary Outcome Measures:
  • complication rate

Estimated Enrollment: 50
Study Start Date: March 2007
Estimated Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00447031

Contacts
Contact: Hyoung Jun Koh 82-2-2228-3570 hjkoh@yumc.yonsei.ac.kr

Locations
Korea, Republic of
Department of Ophthalmology, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of, 120-752
Principal Investigator: Hyoung Jun Koh            
Sponsors and Collaborators
Yonsei University
Investigators
Principal Investigator: Hyoung Jun Koh YUMC
  More Information

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 Feb 28; [Epub ahead of print]
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.
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.
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. 2006 Dec 21; [Epub ahead of print]
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):507-509. Epub 2006 Dec 8.
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 Feb 26; [Epub ahead of print]

Study ID Numbers: koh02
Study First Received: March 12, 2007
Last Updated: January 28, 2008
ClinicalTrials.gov Identifier: NCT00447031  
Health Authority: South Korea: Institutional Review Board

Keywords provided by Yonsei University:
age related macular degeneration
intravitreal bevacizumab
intravitreal triamcinolone acetonide
neovascular age related macular degeneration

Study placed in the following topic categories:
Triamcinolone Acetonide
Eye Diseases
Triamcinolone
Retinal Degeneration
Macular Degeneration
Triamcinolone diacetate
Bevacizumab
Retinal Diseases
Triamcinolone hexacetonide
Retinal degeneration

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Enzyme Inhibitors
Glucocorticoids
Hormones
Immunosuppressive Agents
Angiogenesis Inhibitors
Pharmacologic Actions
Therapeutic Uses
Growth Inhibitors
Angiogenesis Modulating Agents

ClinicalTrials.gov processed this record on January 16, 2009