Cohort Study of the Clinical Course of Macular Diseases in Japanese

Macular Disease Clinical Trial

Official title:

Cohort Study of the Clinical Course of Macular Diseases in Japanese Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02081339
• Other study ID #: E2038
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2014
• Last updated: September 22, 2016
• Start date: March 2014
• Est. completion date: March 2024

Study information

• Verified date: September 2016
• Source: Kyoto University, Graduate School of Medicine
• Contact: Akitaka Tsujikawa, MD
• Phone: +81-75-751-3260
• Email: tujikawa[@]kuhp.kyoto-u.ac.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: March 2024
• Est. primary completion date: March 2022
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Macular Disease

Intervention

Drug:
• ranibizumab, aflibercept, pegaptanib, verteporphin

Locations

Country	Name	City	State
Japan	Kyoto University Graduate School of Medicine	Kyoto

Sponsors (1)

Lead Sponsor	Collaborator
Kyoto University, Graduate School of Medicine

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The change in visual acuity in each macular diseases.		Five years after the registration.	No
Primary	Initial factors associated with visual prognosis in each macular disease		Five years after the registration	No
Secondary	The difference in the visual prognosis depending on the treatments in each macular diseases		Five years after the registration	No