Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Macular Disease Clinical Trial

Official title:

Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02321267
• Other study ID #: H26-035
• Status: Recruiting
• Phase: Phase 4
• First received: December 10, 2014
• Last updated: March 6, 2018
• Start date: December 2014
• Est. completion date: December 2024

Study information

• Verified date: March 2018
• Source: Kagawa University
• Contact: Chika Akuta
• Phone: +81-87-891-2211
• Email: kaomie[@]med.kagawa-u.ac.jp
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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:

Related Conditions & MeSH terms

• Macular Disease

Intervention

Drug:
• 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/?

Locations

Country	Name	City	State
Japan	Kagawa University Faculty of Medicine	Miki	Kagawa

Sponsors (1)

Lead Sponsor	Collaborator
Kagawa University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of best-collected visual acuity from baseline at 5 years		Five years after the registration