Ranibizumab Treatment for Age-Related Macular Degeneretion

Not Applicable

• Conditions: Visual Disorder Due to Age-related Macula Degeneration
• Interventions: Drug: Intravitreal Lucentis 0.5mg

• Registration Number: NCT02158624
• Lead Sponsor: Kyushu University

Brief Summary

To establish the correlation between visual acuity improvement and QOL measurement after ranibizumab treatment for AMD patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Status Verified: 2014-06
• Study First Submitted: 2014-06-05
• Study First Submitted QC: 2014-06-05
• Last Update Submitted: 2014-06-05
• Study First Posted: 2014-06-09
• Last Update Posted: 2014-06-09
• Primary Completion: 2015-04
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Active primary or recurrent subfoveal choroidal neovascularization lesion due to AMD
• Subjects of either gender age 50 years or older
• Visual acuity better than 0.05 decimal( 20/400 Snellen)
• Signed informed consent form

Exclusion Criteria

• Prior treatment for neovascular AMD in the study eye, for example, PDT or anti-VEGF therapy
• Patients whose lesion site evaluated by FA examination is more than 12DA in subject eye
• Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye
• Patients with a history of intraocular surgical operation(including cataract)within 3 months in subject eye
• Patients with serious allergic history to such as fluorescein, indocyanine green, iodophors
• The pregnant or lactating woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ranibizumab	Intravitreal Lucentis 0.5mg	-

Primary Outcome Measures

Name	Time	Method
Baseline change of visual acuity and QOL after ranibizumab treatment	3 months	Analyze the correlation between visual acuity improvement and QOL assessment using VFQ-25 and Patient Satisfaction Questionnaire before and after initial ranibizumab treatment for AMD patients.

Secondary Outcome Measures

Name	Time	Method
To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations	1year

Trial Locations

Locations (1)

Department of Ophthalmology, Kyushu University Hospital; 🇯🇵 Maidashi, Higashiku, Fukuoka-city, Fukuoka, Japan