Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Phase 4

Recruiting

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

• Registration Number: NCT02321267
• Lead Sponsor: Kagawa University

Brief Summary

Macular diseases often cases severe visual impairment. Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of various 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. The advance in vitrectomy improve visual outcomes in some maculae diseases, including epiretinal membrane (ERM), macular hole (MH), vitreomacular traction syndrome (VMTS).

Patients with such macular diseases are registered 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 Start: 2014-12
• Study First Submitted: 2014-12-10
• Study First Submitted QC: 2014-12-16
• Study First Posted: 2014-12-22
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-06
• Last Update Posted: 2018-03-07
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

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

Inclusion Criteria

• Patients who visit Department of Ophthalmology, Kagawa University Hospital with macular diseases, such as AMD, PCV, RAP, RVO, DME, ERM, MH, VMTS.
• Patients who are agreed with the participation of this study.

Exclusion Criteria

• None

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Macular disease with adequate treatments	ranibizumab, aflibercept, pegaptanib, verteporphin	Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.

Primary Outcome Measures

Name	Time	Method
Change of best-collected visual acuity from baseline at 5 years	Five years after the registration

Trial Locations

Locations (1)

Kagawa University Faculty of Medicine; 🇯🇵 Miki, Kagawa, Japan