Ranibizumab Treatment for Age-Related Macular Degeneretion

Visual Disorder Due to Age-related Macula Degeneration Clinical Trial

— QUATRO  

Official title:

The Correlation for Improvement of Visual Acuity and QOL After Ranibizmab Treatment for Age-Related Macular Degeneration Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02158624
• Other study ID #: 13-E-09
• Status: Recruiting
• Phase: N/A
• First received: June 5, 2014
• Last updated: June 5, 2014
• Start date: December 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2014
• Source: Kyushu University
• Contact: Tatsuro Ishibashi, MD. PhD
• Phone: +81-92-642-5648
• Email: ishi[@]eye.med.kyushu-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Vision Disorders
• Visual Disorder Due to Age-related Macula Degeneration

Intervention

Drug:
• Intravitreal Lucentis 0.5mg

Locations

Country	Name	City	State
Japan	Department of Ophthalmology, Kyushu University Hospital	Maidashi, Higashiku, Fukuoka-city	Fukuoka

Sponsors (6)

Lead Sponsor	Collaborator
Kyushu University	Clinical Research Support Center Kyush, Fukuoka University, Kurume University, Novartis, University of Occupational and Environmental Health

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Baseline change of central retinal thickness by OCT examination.		3 months, 1 year	No
Primary	Baseline change of visual acuity and QOL after ranibizumab treatment	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.	3 months	No
Secondary	To evaluate the correlation between the changes of visual acuity and QOL measurement during one year follow-up observations		1year	No