Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Overview

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.

Full Title of Study: “Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)”

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2024

Interventions

  • 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/㎡

Arms, Groups and Cohorts

  • Other: Macular disease with adequate treatments
    • Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.

Clinical Trial Outcome Measures

Primary Measures

  • Change of best-collected visual acuity from baseline at 5 years
    • Time Frame: Five years after the registration

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Kagawa University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Akitaka Tsujikawa, Professor and Chairman – Kagawa University
  • Overall Official(s)
    • Akiataka Tsujikawa, MD, Principal Investigator, Kagawa Univerisity Faculty of Medicine
  • Overall Contact(s)
    • Chika Akuta, +81-87-891-2211, kaomie@med.kagawa-u.ac.jp

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