Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
NCT ID: NCT01810042
Last Updated: 2016-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
49 participants
INTERVENTIONAL
2010-10-31
2013-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity monthly 3 times for the 3 months then pro-re-nata (PRN) for following 3 months.
ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Interventions
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ranibizumab
0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
3. Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
4. Area of CNV clearly visible in ICGA is more than half of the total CNV area.
Exclusion Criteria
2. Blocked fluorescence in ICGA is more than half of the total CNV area.
3. Disciform scar
4. Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
5. Previous any treatment of photodynamic therapy or photocoagulation
6. Previous intraocular or periocular injection of steroid within 3 months
7. Previous intraocular surgery except cataract surgery
8. Vitreo-retinal interface disease on the macula
9. Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
10. Uncontrolled periocular or intraocular infection
11. History of hypersensitivity to ranibizumab treatment
12. Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)
50 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Pusan National University Hospital
OTHER
Responsible Party
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Ji Eun Lee
Associate professor
Principal Investigators
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Ji Eun Lee, MH, PhD
Role: PRINCIPAL_INVESTIGATOR
Pusan National Universtiy Hospital
Locations
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Pusan National University Hospital
Busan, , South Korea
Haeundae Baik Hospital
Busan, , South Korea
Countries
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References
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Wong TY, Knudtson MD, Klein R, Klein BE, Meuer SM, Hubbard LD. Computer-assisted measurement of retinal vessel diameters in the Beaver Dam Eye Study: methodology, correlation between eyes, and effect of refractive errors. Ophthalmology. 2004 Jun;111(6):1183-90. doi: 10.1016/j.ophtha.2003.09.039.
Rosenfeld PJ, Brown DM, Heier JS, Boyer DS, Kaiser PK, Chung CY, Kim RY; MARINA Study Group. Ranibizumab for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1419-31. doi: 10.1056/NEJMoa054481.
Brown DM, Kaiser PK, Michels M, Soubrane G, Heier JS, Kim RY, Sy JP, Schneider S; ANCHOR Study Group. Ranibizumab versus verteporfin for neovascular age-related macular degeneration. N Engl J Med. 2006 Oct 5;355(14):1432-44. doi: 10.1056/NEJMoa062655.
Spaide RF. Rationale for combination therapies for choroidal neovascularization. Am J Ophthalmol. 2006 Jan;141(1):149-56. doi: 10.1016/j.ajo.2005.07.025.
Other Identifiers
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임상20120178
Identifier Type: -
Identifier Source: org_study_id
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