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Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration

This study has been completed.
Sponsor:
Information provided by:
Kumamoto University
ClinicalTrials.gov Identifier:
NCT01032109
First received: December 12, 2009
Last updated: December 14, 2009
Last verified: May 2008

December 12, 2009
December 14, 2009
October 2006
May 2008   (final data collection date for primary outcome measure)
Visual acuity [ Time Frame: The comparison between baseline and 12-month ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01032109 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Age-related Macular Degeneration
Verteporfin Photodynamic Therapy Alone Versus Combined With Intravitreal Bevacizumab for Neovascular Age-related Macular Degeneration

The purpose of this study is to compare 12-month results of two single initial treatments—photodynamic therapy with verteporfin alone and this therapy combined with intravitreal bevacizumab—for neovascular age-related macular degeneration, not including patients with polypoidal choroidal vasculopathy who were presumed to have age-related macular degeneration.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Age-Related Macular Degeneration
Drug: Bevacizumab
A single intravitreal injection of 1.25 mg of bevacizumab (0.05 mL of solution prepared from Avastin, 100 mg/4 mL vial) was performed within 2 weeks after PDT treatment.
Other Name: Avastin
Experimental: Bevacizumab
Intervention: Drug: Bevacizumab
Hara R, Kawaji T, Inomata Y, Tahara J, Sagara N, Fukushima M, Tanihara H. Photodynamic therapy alone versus combined with intravitreal bevacizumab for neovascular age-related macular degeneration without polypoidal choroidal vasculopathy in Japanese patients. Graefes Arch Clin Exp Ophthalmol. 2010 Jul;248(7):931-6. doi: 10.1007/s00417-010-1343-8. Epub 2010 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
May 2008
May 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • choroidal neovascularization caused by age-related macula degeneration
  • no previous treatment
  • a follow-up at least 12 months
  • a baseline visual acuity ranging from a letter score of 0 to 70 on the Early Treatment Diabetic Retinopathy Study chart

Exclusion Criteria:

  • choroidal neovascularization caused by other eye diseases
  • ocular surgery within the past 3 mouths
  • history of uveitis
  • intraocular pressure higher than 25 mmHg, or glaucoma
  • history of systemic or ocular thromboembolic events.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01032109
PCBK610
No
Takahiro Kawaji, Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
Kumamoto University
Not Provided
Principal Investigator: Takahiro Kawaji, MD, PhD Department of Ophthalmology, Kumamoto University Graduate School & Medical Sciences
Kumamoto University
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP