Cohort Study of the Clinical Course of Macular Diseases in Japanese

September 22, 2016 updated by: Nagahisa Yoshimura, Kyoto University, Graduate School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Kyoto, Japan, 606-8507
        • Recruiting
        • Kyoto University Graduate School of Medicine
        • Contact:
        • Principal Investigator:
          • Akitaka Tsujikawa, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Initial factors associated with visual prognosis in each macular disease
Time Frame: Five years after the registration
Five years after the registration

Secondary Outcome Measures

Outcome Measure
Time Frame
The difference in the visual prognosis depending on the treatments in each macular diseases
Time Frame: Five years after the registration
Five years after the registration

Other Outcome Measures

Outcome Measure
Time Frame
The change in visual acuity in each macular diseases.
Time Frame: Five years after the registration.
Five years after the registration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyoto University, Graduate School of Medicine

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2024

Study Registration Dates

First Submitted

January 22, 2014

First Submitted That Met QC Criteria

March 5, 2014

First Posted (Estimate)

March 7, 2014

Study Record Updates

Last Update Posted (Estimate)

September 23, 2016

Last Update Submitted That Met QC Criteria

September 22, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2038

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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