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Cohort Study of the Clinical Course of Macular Diseases in Kagawa

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02321267
Recruitment Status : Recruiting
First Posted : December 22, 2014
Last Update Posted : March 7, 2018
Information provided by (Responsible Party):
Akitaka Tsujikawa, 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.

Condition or disease Intervention/treatment Phase
Macular Disease Drug: ranibizumab, aflibercept, pegaptanib, verteporphin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)
Study Start Date : December 2014
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Macular disease with adequate treatments
Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.
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/㎡
Other Name: Lucentis, Eylea, Macugen, Vizudyne

Primary Outcome Measures :
  1. Change of best-collected visual acuity from baseline at 5 years [ Time Frame: Five years after the registration ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02321267

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Contact: Chika Akuta +81-87-891-2211

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Kagawa University Faculty of Medicine Recruiting
Miki, Kagawa, Japan, 761-0793
Contact    +81878912211   
Sponsors and Collaborators
Kagawa University
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Principal Investigator: Akiataka Tsujikawa, MD Kagawa Univerisity Faculty of Medicine
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Responsible Party: Akitaka Tsujikawa, Professor and Chairman, Kagawa University Identifier: NCT02321267    
Other Study ID Numbers: H26-035
First Posted: December 22, 2014    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Keywords provided by Akitaka Tsujikawa, Kagawa University:
Additional relevant MeSH terms:
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Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Photosensitizing Agents
Dermatologic Agents