Ranibizumab for Exudative Age-Related Macular Degeneratio

Phase 4

• Conditions: age-related macular degeneration; H353

• Registration Number: JPRN-jRCTs021180003
• Lead Sponsor: Saito Masaaki

Brief Summary

70 eyes were enrolled in this study. However, we reluctantly abandoned for evaluating the efficacy for the mean change in best-corrected visual acuity from baseline at Month 12 due to discontinuance the study. But we made confirmmation the safety in this study.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-04
• Study Completion: 2019-08-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1) naive neovascular AMD with older than 50 years and acceptance of this study
2) typical AMD

Exclusion Criteria

1) previous treatment for AMD
2) polypoidal choroidal vasculopathy
3) retinal angiomatous proliferation
4) diabetic maculopathy, retinal vascular occlusion, or idiopathic macular telangiectasia

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The mean changes of best-corrected visual acuity at month 24 compared with baseline

Secondary Outcome Measures

Name	Time	Method
The prevalence of eyes with only ranibizumab by PRN (pro re nata)