Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Sponsor

Kagawa University (Other)

Overall Status

Recruiting

CT.gov ID

NCT02321267

Collaborator

(none)

1,000

Enrollment

Location

Arm

120

Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Anticipated 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 :

Dec 1, 2014

Anticipated Primary Completion Date :

Dec 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Other: 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 Names: Lucentis, Eylea, Macugen, Vizudyne

Arm

Intervention/Treatment

Other: 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 Names:

Lucentis, Eylea, Macugen, Vizudyne

Outcome Measures

Primary Outcome Measures

Change of best-collected visual acuity from baseline at 5 years [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, 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.