NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221648

Registered date:11/11/2011

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedSubfoveal choroidal neovascularization secondary to age-related macular degeneration
Date of first enrollment11/11/2011
Target sample size
Countries of recruitment
Study typeInterventional
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 OutcomeEfficacy and safety
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 50age old
Age maximumNot applicable
GenderBoth
Include criteria1) 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 criteria1) 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

Contact

Public contact
Name
Address n_kuboyama@mb5.skk-net.com
Telephone
E-mail
Affiliation SANWA KAGAKU KENKYUSHO CO.,LTD.
Scientific contact
Name
Address
Telephone
E-mail
Affiliation