Cohort Study of the Clinical Course of Macular Diseases in Japanese

Sponsor

Kyoto University, Graduate School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT02081339

Collaborator

(none)

1,000

Enrollment

Location

120

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Disease	Drug: ranibizumab, aflibercept, pegaptanib, verteporphin

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2014

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Macular diseases 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/㎡	Drug: ranibizumab, aflibercept, pegaptanib, verteporphin

Arm

Intervention/Treatment

Macular diseases

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/㎡

Drug: ranibizumab, aflibercept, pegaptanib, verteporphin

Outcome Measures

Primary Outcome Measures

Initial factors associated with visual prognosis in each macular disease [Five years after the registration]

Secondary Outcome Measures

The difference in the visual prognosis depending on the treatments in each macular diseases [Five years after the registration]

Other Outcome Measures

The change in visual acuity in each macular diseases. [Five years after the registration.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kyoto University Graduate School of Medicine	Kyoto		Japan	606-8507

Sponsors and Collaborators

Kyoto University, Graduate School of Medicine

Investigators

Study Chair: Nagahisa Yoshimura, MD, Kyoto University, Graduate School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nagahisa Yoshimura, Professor, Kyoto University, Graduate School of Medicine

ClinicalTrials.gov Identifier:

NCT02081339

Other Study ID Numbers:

E2038

First Posted:

Mar 7, 2014

Last Update Posted:

Sep 23, 2016

Last Verified:

Sep 1, 2016

Additional relevant MeSH terms:

Ranibizumab

Aflibercept

Verteporfin

Study Results

No Results Posted as of Sep 23, 2016