To Compare Anti-VEGF Monotherapy With Anti-VEGF and EPM Grid Laser Combination Therapy for Diabetic Macular Edema

Summary

Objectives:

To compare the efficacy of monotherapy with anti-Vascular Endothelial Growth Factor (ranibizumab or bevacizumab) with combined therapy with anti-Vascular Endothelial Growth Factor and end-point-management grid laser photocoagulation for diabetic macular edema.

Study design:

Open-label non-randomized interventional study.

Study overview:

This study aims to look at the efficacy of treating diabetic macular edema (DME) with either anti-Vascular Endothelial Growth Factor(anti-VEGF) monotherapy, compared with combination therapy with anti-VEGF and End-Point-Management (EPM) grid laser photocoagulation, over a period of 6 months.

Various sites from across Asia (Japan, South Korea, Hong Kong) will participate. Depending on the availability of EPM laser, sites can either contribute to the 'Anti-VEGF monotherapy' arm, or to the 'Combination therapy' arm.

Conditions

• Diabetic Macula Edema

Interventions

PROCEDURE

End-Point-Management grid laser

DRUG

ranibizumab

DRUG

Bevacizumab

Sponsors & Collaborators

• Nagoya City University

  collaborator OTHER

• Asahikawa Medical College

  collaborator OTHER

• University of Fukui

  collaborator OTHER

• Eguchi Eye Clinic

  collaborator OTHER

• Kyoto University

  collaborator OTHER

• Nagasaki University

  collaborator OTHER

• Osaka Medical College

  collaborator OTHER

• Kyushu University

  collaborator OTHER

• Tokyo Medical University Hachioji Medical Centre

  collaborator UNKNOWN

• Hokkaido University

  collaborator OTHER

• Kyorin University

  collaborator OTHER

• Inje University

  collaborator OTHER

• Pusan National University

  collaborator OTHER

• Kyungpook National University Hospital

  collaborator OTHER

• Chungnam National University Hospital

  collaborator OTHER

• Sun Cheon Hyang University

  collaborator UNKNOWN

• Kyunghee University

  collaborator OTHER

• Yeungnam University Hospital

  collaborator OTHER

• Korea University

  collaborator OTHER

• National University Hospital, Singapore

  collaborator OTHER

• Yamagata University

  collaborator OTHER

• The University of Hong Kong

  lead OTHER

Principal Investigators

• Ian Wong, FRCOphth · The University of Hong Kong

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2015-06-30

Primary Completion

2017-06-30

Completion

2017-12-31

Countries

• China

Study Locations