Status:
COMPLETED
Indocyanine Angiographic Changes of Choroidal Neovascularization by Ranibizumab
Lead Sponsor:
Pusan National University Hospital
Collaborating Sponsors:
Novartis
Conditions:
Exudative Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
Exudative age-related macular degeneration (ARMD) is complicated by choroidal neovascularization (CNV). Although anti-vascular endothelial growth factor treatment is the gold standard treatment, recur...
Detailed Description
For patients having exudative ARMD with CNV, whose vascular structures are clearly demonstrated in ICGA , ranibizumab is injected monthly three times, then pro re nata to 6 months. Vascular structures...
Eligibility Criteria
Inclusion
- age \>= 50
- Visual acuity of the study eye is between 20/400 and 20/40, and the other eye is 20/400 or better
- Area of choroidal new vessel (CNV) clearly visible in indocyanine green angiography (ICGA) is more then 1/2 disc area.
- Area of CNV clearly visible in ICGA is more than half of the total CNV area.
Exclusion
- CNV caused by other than age-related macular degeneration. (polypoidal choroidal vascularization, retinal angiomatous proliferation, degenerative myopia etc)
- Blocked fluorescence in ICGA is more than half of the total CNV area.
- Disciform scar
- Previous anti-vascular endothelial growth factor (VEGF) treatment within 3 months
- Previous any treatment of photodynamic therapy or photocoagulation
- Previous intraocular or periocular injection of steroid within 3 months
- Previous intraocular surgery except cataract surgery
- Vitreo-retinal interface disease on the macula
- Presence of other diseases may affect visual acuity (uveitis, glaucoma, diabetic retinopathy, etc.)
- Uncontrolled periocular or intraocular infection
- History of hypersensitivity to ranibizumab treatment
- Uncontrolled systemic diseases (hypertension, diabetes mellitus, etc.)
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01810042
Start Date
October 1 2010
End Date
February 1 2013
Last Update
May 4 2016
Active Locations (2)
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1
Pusan National University Hospital
Busan, South Korea, 602-739
2
Haeundae Baik Hospital
Busan, South Korea, 612-896