Cohort Study of the Clinical Course of Macular Diseases in Japanese

• Conditions: Macular Disease
• Interventions: Drug: ranibizumab, aflibercept, pegaptanib, verteporphin

• Registration Number: NCT02081339
• Lead Sponsor: Kyoto University, Graduate School of Medicine

Brief Summary

Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of macular diseases, including age-related macular degeneration (AMD), polypoidal choroidal vasculopathy (PCV), retinal angiomatous proliferation (RAP), central serous chorioretinopathy (CSC), myopic choroidal neovascularization (CNV), retinal vein occlusion (RVO), diabetic macular edema (DME), and so forth.

Patients with such macular diseases are registered and and are followed up for 5 years with appropriate treatment for each patient. By the analysis of the correlation between initial examinations and final visual acuity, factors associated with good visual prognosis will be elucidated.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-22
• Study Start: 2014-03
• Study First Submitted QC: 2014-03-05
• Study First Posted: 2014-03-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23
• Primary Completion: 2022-03
• Study Completion: 2024-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
• Patients who are agreed with the participation of this study.

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Macular diseases	ranibizumab, aflibercept, pegaptanib, verteporphin	ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡

Primary Outcome Measures

Name	Time	Method
Initial factors associated with visual prognosis in each macular disease	Five years after the registration

Secondary Outcome Measures

Name	Time	Method
The difference in the visual prognosis depending on the treatments in each macular diseases	Five years after the registration

Trial Locations

Locations (1)

Kyoto University Graduate School of Medicine; 🇯🇵 Kyoto, Japan