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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02321267
Other study ID # H26-035
Secondary ID
Status Recruiting
Phase Phase 4
First received December 10, 2014
Last updated March 6, 2018
Start date December 2014
Est. completion date December 2024

Study information

Verified date March 2018
Source Kagawa University
Contact Chika Akuta
Phone +81-87-891-2211
Email kaomie@med.kagawa-u.ac.jp
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1000
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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:

Study Design


Related Conditions & MeSH terms


Intervention

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/?

Locations

Country Name City State
Japan Kagawa University Faculty of Medicine Miki Kagawa

Sponsors (1)

Lead Sponsor Collaborator
Kagawa University

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of best-collected visual acuity from baseline at 5 years Five years after the registration
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