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

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ClinicalTrials.gov Identifier: NCT02462304
Recruitment Status : Unknown
Verified April 2016 by Dr. WONG Yat-hin Ian, The University of Hong Kong.
Recruitment status was:  Enrolling by invitation
First Posted : June 4, 2015
Last Update Posted : April 19, 2016
Sponsor:
Collaborators:
Nagoya City University
Asahikawa Medical College
University of Fukui
Eguchi Eye Clinic
Kyoto University
Nagasaki University
Osaka Medical College
Kyushu University
Tokyo Medical University Hachioji Medical Centre
Hokkaido University
Kyorin University
Inje University
Pusan National University
Kyungpook National University
Chungnam National University Hospital
Sun Cheon Hyang University
Kyunghee University
Yeungnam University Hospital
Korea University
National University Hospital, Singapore
Yamagata University
Information provided by (Responsible Party):
Dr. WONG Yat-hin Ian, The University of Hong Kong

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.


Condition or disease Intervention/treatment Phase
Diabetic Macula Edema Procedure: End-Point-Management grid laser Drug: ranibizumab Drug: Bevacizumab Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: To Compare the Efficacy of Monotherapy With Anti-Vascular Endothelial Growth Factor (Ranibizumab or Bevacizumab) Versus Combination Therapy With Anti-Vascular Endothelial Growth Factor and End-point-management Grid Laser Photocoagulation for Diabetic Macular Edema
Study Start Date : June 2015
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Arm Intervention/treatment
Experimental: Combination Anti-VEGF and EPM laser
Subjects will receive both anti-VEGF injections and EPM laser.
Procedure: End-Point-Management grid laser
Drug: ranibizumab
Drug: Bevacizumab
Active Comparator: Anti-VEGF monotherapy
Subjects will receive anti-VEGF injections monotherapy.
Drug: ranibizumab
Drug: Bevacizumab



Primary Outcome Measures :
  1. Difference in number of anti-VEGF required [ Time Frame: 6 months ]
    The number of injections of anti-VEGF required at the end of the 6 months period.


Secondary Outcome Measures :
  1. Change in best corrected visual acuity [ Time Frame: 6 months ]
    The change in best corrected visual acuity among subjects in different groups at the end of the 6 months period when compared to baseline.

  2. Central retinal thickness [ Time Frame: 6 months ]
    The change in central retinal thickness among subjects in different groups at the end of the 6 months period when compared to baseline.

  3. Treatment related complications [ Time Frame: 6 months ]
    This will look at treatment related complications in terms of changes in intraocular pressure post-injection

  4. Treatment related complications [ Time Frame: 6 months ]
    This will look at treatment related complications in terms of infection

  5. Treatment related complications [ Time Frame: 6 months ]
    This will look at treatment related complications in terms of retinal detachment

  6. Recurrence of macular edema [ Time Frame: 6 months ]
    Recurrence of macular edema during the 6 months period will be monitored.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • Systemic Exclusion Criteria: A subject is not eligible if any of the following exclusion criteria are present:
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02462304


Locations
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China
The University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Nagoya City University
Asahikawa Medical College
University of Fukui
Eguchi Eye Clinic
Kyoto University
Nagasaki University
Osaka Medical College
Kyushu University
Tokyo Medical University Hachioji Medical Centre
Hokkaido University
Kyorin University
Inje University
Pusan National University
Kyungpook National University
Chungnam National University Hospital
Sun Cheon Hyang University
Kyunghee University
Yeungnam University Hospital
Korea University
National University Hospital, Singapore
Yamagata University
Investigators
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Principal Investigator: Ian Wong, FRCOphth The University of Hong Kong

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Responsible Party: Dr. WONG Yat-hin Ian, Clinical Assistant Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT02462304     History of Changes
Other Study ID Numbers: END-DME1
First Posted: June 4, 2015    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Dr. WONG Yat-hin Ian, The University of Hong Kong:
Diabetic Macula Edema
End-Point-Management
ranibizumab
bevacizumab

Additional relevant MeSH terms:
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Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Bevacizumab
Ranibizumab
Endothelial Growth Factors
Antineoplastic Agents, Immunological
Antineoplastic Agents
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors