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

Not Applicable

• Conditions: Age-related macular degeneration

• Registration Number: JPRN-UMIN000012013
• Lead Sponsor: Clinical Research Support Center Kyushu

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-01
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients whose lesion site evaluated by FA examination is more than 12 optic disc areas (1 optic disc area is 30.5mm2, a lesion including a bleeding, scar and neo-vascularization) in subject eye. 2) Patient with a scar or fibrosis in the range more than 50% of all lesions in subject eye. 3) Patients with a history of retinal pigment epithelium tear or rupture in subject eye. 4) Patients with a history of more than stage 3 macular hole in subject eye. 5) Patients with treatment of triamcinolone intravitreal injection within 6 months in subject eye. 6) Patient with a history of intraocular surgical operation (including cataract) within 3 months in subject eye. 7) Patient with a history of surgical operation such as vitrectomy and submacular surgery in subject eye. 8) Patients with intraocular, extraocular and periocular inflammation or infectious in either eye. 9) Patients with a history of uveitis in either eye. 10) Patients with serious allergic history to such as fluoresceine, indocyanine green, iodo. 11) Women who have pregnancy, possibility of the pregnancy or are nursing. 12) Any other patients who are regarded as unsuitable for this study by the investigators

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Baseline change of best-corrected visual acuity (LogMAR) and QOL (VFQ-25) 3 months after ranibizumab administration.

Secondary Outcome Measures

Name	Time	Method
1) Baseline change of best-corrected visual acuity (LogMAR) just before and 12 months after ranibizumab administration. 2) Baseline change of QOL (VFQ-25) just before and 12 months after ranibizumab administration. 3) Baseline change of central retinal thickness by OCT examination just before, 3 months and 12 months after ranibizumab administration. 4) Patient rate of exudative change (subretinal fluid, retinal edema and serous retinal pigment epithelial detachment) just before, 3 months and 12 months after ranibizumab administration. 5) Baseline change of greatest linear dimension just before, 3 months and 12 months after ranibizumab administration. 6) Baseline change of patient satisfaction questionnaire just before, 3 months and 12 months after ranibizumab administration.