JRCT ID: jRCT2080221648
Registered date:11/11/2011
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | Subfoveal choroidal neovascularization secondary to age-related macular degeneration |
Date of first enrollment | 11/11/2011 |
Target sample size | |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : SK-1011 INN of investigational material : Therapeutic category code : 131 Agents for ophthalmic use Dosage and Administration for Investigational material : oral administration, 60mg BID (twice a day) control material(s) Generic name etc : Placebo INN of investigational material : Therapeutic category code : --- Other Dosage and Administration for Investigational material : oral administration, BID (twice a day) |
Outcome(s)
Primary Outcome | Efficacy and safety |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 50age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | 1) Age-related macular degeneration patients diagnosed with subfoveal choroidal neovascularization in the study eye 2) Patients who have a BCVA ETDRS score between 73 and 24 letters in the study eye inclusive (approximately 0.5 to 0.06) 3) Patients who are capable of giving written informed consent |
Exclude criteria | 1) Use of systemic anti-VEGF medication 2) Prior treatment in the study eye with anti-VEGFs, verteporfin, steroids, or laser photocoagulation within certain periods of time 3) Presence of retinal angiomatous proliferation (RAP) in the study eye 4) Medical conditions such as cancer, serious liver, renal cardiac disease |
Related Information
Primary Sponsor | SANWA KAGAKU KENKYUSHO CO.,LTD. |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-111690 |
Contact
Public contact | |
Name | |
Address | n_kuboyama@mb5.skk-net.com |
Telephone | |
Affiliation | SANWA KAGAKU KENKYUSHO CO.,LTD. |
Scientific contact | |
Name | |
Address | |
Telephone | |
Affiliation |