search
Back to results

Combination Therapy for Neovascular Age Related Macular Degeneration

Primary Purpose

Macular Degeneration

Status
Withdrawn
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
intravitreal bevacizumab and triamcinolone acetonide
Sponsored by
Yonsei University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Macular Degeneration focused on measuring age related macular degeneration, intravitreal bevacizumab, intravitreal triamcinolone acetonide, neovascular age related macular degeneration

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Ophthalmology, Yonsei University College of Medicine

Outcomes

Primary Outcome Measures

recurrence rate
best corrected visual acuity

Secondary Outcome Measures

complication rate

Full Information

First Posted
March 12, 2007
Last Updated
February 5, 2010
Sponsor
Yonsei University
search

1. Study Identification

Unique Protocol Identification Number
NCT00447031
Brief Title
Combination Therapy for Neovascular Age Related Macular Degeneration
Official Title
Intravitreal Bevacizumab Combined With Intravitreal Triamcinolone Acetonide Injection Versus Intravitreal Bevacizumab for Age Related Macular Degeneration
Study Type
Interventional

2. Study Status

Record Verification Date
March 2009
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient patients who met inclusion criteria
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
November 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Yonsei University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Degeneration
Keywords
age related macular degeneration, intravitreal bevacizumab, intravitreal triamcinolone acetonide, neovascular age related macular degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
intravitreal bevacizumab and triamcinolone acetonide
Primary Outcome Measure Information:
Title
recurrence rate
Title
best corrected visual acuity
Secondary Outcome Measure Information:
Title
complication rate

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyoung Jun Koh
Organizational Affiliation
YUMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Ophthalmology, Yonsei University College of Medicine
City
Seoul
ZIP/Postal Code
120-752
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
17333238
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. doi: 10.1007/s00417-007-0557-x. Epub 2007 Feb 28.
Results Reference
background
PubMed Identifier
17290193
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. doi: 10.1097/IAE.0b013e3180323de7.
Results Reference
background
PubMed Identifier
17151484
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. doi: 10.1097/01.iae.0000247164.70376.91.
Results Reference
background
PubMed Identifier
17186262
Citation
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.
Results Reference
background
PubMed Identifier
17317397
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. doi: 10.1016/j.ajo.2006.10.050. Epub 2006 Dec 8.
Results Reference
background
PubMed Identifier
17324219
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. doi: 10.1111/j.1600-0420.2007.00891.x. Epub 2007 Feb 27.
Results Reference
background

Learn more about this trial

Combination Therapy for Neovascular Age Related Macular Degeneration

We'll reach out to this number within 24 hrs