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Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Primary Purpose

Macular Disease

Status

Recruiting

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

ranibizumab, aflibercept, pegaptanib, verteporphin

About this trial

This is an interventional treatment trial for Macular Disease focused on measuring AMD, PCV, RAP, RVO, DME, ERM, MH, mCNV

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Exclusion Criteria:

None

Sites / Locations

Kagawa University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Macular disease with adequate treatments

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02321267

First Posted

December 10, 2014

Last Updated

March 6, 2018

Sponsor

Kagawa University

1. Study Identification

Unique Protocol Identification Number

NCT02321267

Brief Title

Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Official Title

Cohort Study of the Clinical Course of Macular Diseases in Kagawa (Kagawa Macula Cohort Study)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Recruiting

Study Start Date

December 2014 (undefined)

Primary Completion Date

December 2024 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Kagawa University

4. Oversight

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Macular Disease

Keywords

AMD, PCV, RAP, RVO, DME, ERM, MH, mCNV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Macular disease with adequate treatments

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

ranibizumab, aflibercept, pegaptanib, verteporphin

Other Intervention Name(s)

Lucentis, Eylea, Macugen, Vizudyne

Intervention Description

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/㎡

Primary Outcome Measure Information:

Title

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

Time Frame

Five years after the registration

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chika Akuta

Phone

+81-87-891-2211

kaomie@med.kagawa-u.ac.jp

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Akiataka Tsujikawa, MD

Organizational Affiliation

Kagawa Univerisity Faculty of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Kagawa University Faculty of Medicine

City

Miki

State/Province

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Individual Site Status

Recruiting

Facility Contact:

Phone

+81878912211

chosa@med.kagawa-u.ac.jp

12. IPD Sharing Statement

Learn more about this trial

Cohort Study of the Clinical Course of Macular Diseases in Kagawa

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