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

NCT ID: NCT02462304

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-06-30
• Study Completion Date: 2017-12-31

Brief 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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Combination Anti-VEGF and EPM laser

Subjects will receive both anti-VEGF injections and EPM laser.

Group Type: EXPERIMENTAL

End-Point-Management grid laser

Intervention Type: PROCEDURE

ranibizumab

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Anti-VEGF monotherapy

Subjects will receive anti-VEGF injections monotherapy.

Group Type: ACTIVE_COMPARATOR

ranibizumab

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Interventions

End-Point-Management grid laser

Intervention Type: PROCEDURE

ranibizumab

Intervention Type: DRUG

Bevacizumab

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥ 18 years with CSME
• Diagnosis of diabetes mellitus (type 1 or type 2)
• At least one eye meets the study eye criteria
• Able and willing to provide informed consent prior to any study-related procedures
• Central foveal thickness ≥ 300 microns at baseline (SPECTRALIS or Cirrus HD OCT)
• LogMAR Best corrected visual acuity 0.20 (Snellen 20/30) to 1.3 (Snellen 20/400).
• Willing and able to comply with clinic visits and study-related procedures
• Central Foveal Thickness on OCT 300-600 micron
• After first injection, wait for ME to reduce before proceeding with the laser. Exclude if ME persists >500um at the 4-week follow up

Exclusion Criteria

• Macular edema is considered to be due to a cause other than diabetic macular edema.
• An ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, VMT, pigment epithelium abnormalities, dense subfoveal hard exudates, non-retinal condition such as glaucoma etc).
• Substantial cataract that, in the opinion of the investigator, is likely to be affecting visual acuity. Likely to be affecting BCVA and performing laser treatment.
• History of treatment for diabetic macular edema at any time in the past (such as grid macular photocoagulation).
• History of treatment for diabetic macular edema at any time in the past 3 months (such as intravitreal or peribulbar corticosteroids, ranibizumab, bevacizumab, aflibercept).
• Focal laser photocoagulation should be performed before enrolling into the study if needed. 3 months gap required between last laser procedure and recruitment.
• History of panretinal (scatter) photocoagulation (PRP) within 3 months prior to enrollment.
• Anticipated need for PRP in the study period.
• History of major retinal surgery (including vitrectomy, scleral buckle, any glaucoma surgery, etc.).
• History of YAG capsulotomy performed within 3 months.
• Aphakia.
• Intraocular pressure ≥ 25 mmHg.
• History of open-angle glaucoma (either primary open-angle glaucoma or other cause of open-angle glaucoma; note: history of angle-closure glaucoma is not an exclusion criterion).
• Exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant Blepharitis.
• Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant.
• A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
• Blood pressure > 180/110 (systolic above 180 OR diastolic above 110).
• Major surgery within 28 days prior to randomization or major surgery planned during the next 6 months.
• Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
• Systemic anti-vascular growth factor (ranibizumab) or pro-VEGF treatment within 4 months.
• For women of childbearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
• Subject is expecting to move out of the area of the clinical center to an area not covered by another clinical center during the study.
• The target eye is the only eye of the subject, with the fellow eye's visual acuity lower than 1.3 LogMAR units.
• Baseline logMAR BCVA from 0.05 to 0.5 (Snellen)
• Fellow eye BCVA 0.05 or worse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nagoya City University

OTHER

Sponsor Role: collaborator

Asahikawa Medical College

OTHER

Sponsor Role: collaborator

University of Fukui

OTHER

Sponsor Role: collaborator

Eguchi Eye Clinic

OTHER

Sponsor Role: collaborator

Kyoto University

OTHER

Sponsor Role: collaborator

Nagasaki University

OTHER

Sponsor Role: collaborator

Osaka Medical College

OTHER

Sponsor Role: collaborator

Kyushu University

OTHER

Sponsor Role: collaborator

Tokyo Medical University Hachioji Medical Centre

UNKNOWN

Sponsor Role: collaborator

Hokkaido University

OTHER

Sponsor Role: collaborator

Kyorin University

OTHER

Sponsor Role: collaborator

Inje University

OTHER

Sponsor Role: collaborator

Pusan National University

OTHER

Sponsor Role: collaborator

Kyungpook National University Hospital

OTHER

Sponsor Role: collaborator

Chungnam National University Hospital

OTHER

Sponsor Role: collaborator

Sun Cheon Hyang University

UNKNOWN

Sponsor Role: collaborator

Kyunghee University

OTHER

Sponsor Role: collaborator

Yeungnam University Hospital

OTHER

Sponsor Role: collaborator

Korea University

OTHER

Sponsor Role: collaborator

National University Hospital, Singapore

OTHER

Sponsor Role: collaborator

Yamagata University

OTHER

Sponsor Role: collaborator

The University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Dr. WONG Yat-hin Ian

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Wong, FRCOphth

Role: PRINCIPAL_INVESTIGATOR

The University of Hong Kong

Locations

The University of Hong Kong

Hong Kong, , China

Countries

China

Other Identifiers

END-DME1

Identifier Type: -

Identifier Source: org_study_id