Ranibizumab Treatment for Age-Related Macular Degeneretion (QUATRO)

Kyushu University

Status: Unknown

Conditions: Visual Disorder Due to Age-related Macula Degeneration

Treatments: Drug: Intravitreal Lucentis 0.5mg

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02158624

13-E-09

Details and patient eligibility

About

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

Enrollment: 100 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Ranibizumab

Experimental group

Treatment:

Drug: Intravitreal Lucentis 0.5mg