Cohort Study of the Clinical Course of Macular Diseases in Japanese

NCT02081339 | Unknown

• 1 other identifier: E2038
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

Recent clinical introduction of anti-vascular endothelial growth factor agents may change the clinical course of 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. Patients with such macular diseases are registered and 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

Outcome Measures

Primary Outcomes (1)

• Initial factors associated with visual prognosis in each macular disease

  Five years after the registration

Secondary Outcomes (1)

• The difference in the visual prognosis depending on the treatments in each macular diseases

  Five years after the registration

Other Outcomes (1)

• The change in visual acuity in each macular diseases.

  Five years after the registration.

Study Arms (1)

Macular diseases

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/㎡

Drug: ranibizumab, aflibercept, pegaptanib, verteporphin

Interventions

ranibizumab, aflibercept, pegaptanib, verteporphin DRUG

Macular diseases

Eligibility Criteria

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

Study Population

Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.

You may qualify if:

• Patients who visit Department of Ophthalmology Kyoto University Hospital with macular diseases.
• Patients who are agreed with the participation of this study.

You may not qualify if:

• None

Sponsors & Collaborators

• Kyoto University, Graduate School of Medicine: lead

Study Sites (1)

Kyoto University Graduate School of Medicine

Kyoto, Kyoto, 606-8507, 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

• Nagahisa Yoshimura, MD

  Kyoto University, Graduate School of Medicine

  STUDY CHAIR

Central Study Contacts

Akitaka Tsujikawa, MD

CONTACT

+81-75-751-3260; tujikawa@kuhp.kyoto-u.ac.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 22, 2014
• First Posted: March 7, 2014
• Study Start: March 1, 2014
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2024
• Last Updated: September 23, 2016

Record last verified: 2016-09

Locations

JP (1)