Status:
COMPLETED
Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration
Lead Sponsor:
Novartis Korea Ltd.
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF) in patients with neovascular age-related macular degeneration receiving c...
Eligibility Criteria
Inclusion
- Signed written informed consent
- Age ≥ 50 years old
- Patients with primary active subfoveal CNV secondary to AMD
- Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/40 to 20/400 using ETDRS chart
- Characteristics of AMD lesion
- predominantly or minimally classic, or occult
- absence of prior subfoveal treatment for macular disease
- total lesion size ≤ 9 optic disc areas, with CNV component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case \< 50% CNV was acceptable)
- active choroidal neovascularization leakage
- submacular blood \< 50% and subretinal fibrosis \< 25% of the total lesion
Exclusion
- additional eye disease that could compromise VA
- CNV unrelated to AMD
- ocular inflammation
- vitreous hemorrhage
- retinal hemorrhage (other than AMD related submacular blood) \> 1 disc areas
- intraocular surgery ≤ 1 month before day 0
- uncontrolled glaucoma
- prior treatments with verteporfin PDT
- laser photocoagulation or other intervention for AMD
- previous treatment with external-beam radiation therapy or transpupillary thermotherapy
- history of vitrectomy
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00967213
Start Date
August 1 2006
Last Update
April 22 2016
Active Locations (1)
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1
Dept. of Ophthalmology, KyungHee Medical Center, #1 Hoegi, Dongdaemun-gu
Seoul, South Korea, 130-702