Cohort Study of the Clinical Course of Macular Diseases in Kagawa

NCT02321267 | Unknown Phase 4

• 1 other identifier: H26-035
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Macular Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  Five years after the registration

Study Arms (1)

Macular disease with adequate treatments

OTHER

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

Drug: ranibizumab, aflibercept, pegaptanib, verteporphin

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/㎡

Also known as: Lucentis, Eylea, Macugen, Vizudyne

Macular disease with adequate treatments

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• None

Sponsors & Collaborators

• Kagawa University: lead

Study Sites (1)

Kagawa University Faculty of Medicine

Hiragi, Kagawa-ken, 761-0793, Japan

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Interventions

Ranibizumab; aflibercept; pegaptanib; Verteporfin

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Porphyrins; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Akiataka Tsujikawa, MD

  Kagawa Univerisity Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chika Akuta

CONTACT

+81-87-891-2211; kaomie@med.kagawa-u.ac.jp

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chairman

Study Record Dates

• First Submitted: December 10, 2014
• First Posted: December 22, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 7, 2018

Record last verified: 2018-03

Locations

JP (1)