Cohort Study of the Clinical Course of Macular Diseases in Kagawa

NCT ID: NCT02321267

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Macular disease with adequate treatments

Macular diseases can be treated with most appropriate treatment, including pegaptanib, ranibizumab, afibercept, visudyne, or vitrectomy.

Group Type OTHER

ranibizumab, aflibercept, pegaptanib, verteporphin

Intervention Type DRUG

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/㎡

Interventions

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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/㎡

Intervention Type DRUG

Other Intervention Names

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Lucentis, Eylea, Macugen, Vizudyne

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kagawa University

OTHER

Sponsor Role lead

Responsible Party

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Akitaka Tsujikawa

Professor and Chairman

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Akiataka Tsujikawa, MD

Role: PRINCIPAL_INVESTIGATOR

Kagawa Univerisity Faculty of Medicine

Locations

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Kagawa University Faculty of Medicine

Hiragi, Kagawa-ken, Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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Chika Akuta

Role: CONTACT

+81-87-891-2211

Facility Contacts

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Role: primary

+81878912211

Other Identifiers

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H26-035

Identifier Type: -

Identifier Source: org_study_id

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