Cohort Study of the Clinical Course of Macular Diseases in Kagawa

Sponsor
Kagawa University
Study ID
NCT02321267
Phase
PHASE4
Status
Unknown

Conditions

  • Macular Disease

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • ranibizumab, aflibercept, pegaptanib, verteporphin — 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/㎡

Study Details

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.

Key Dates

Start date
Dec 31, 2014
Status verified
Mar 2018
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

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

Central Contacts

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