CClinicalTrials.gg
Status unknownNCT02462304END-DMEUpdated Apr 19, 2016

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

A Phase 4 interventional study of End-Point-Management grid laser and ranibizumab in Diabetic Macula Edema, sponsored by The University of Hong Kong. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-19.

Sponsored by The University of Hong Kong · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2016), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetic Macula Edema

Keywords

  • Diabetic Macula Edema
  • End-Point-Management
  • ranibizumab
  • bevacizumab
03

In context

Macular Edema

841 studies on the registry are indexed under Macular Edema; 56 are open to participants now.

This study's planned enrollment of 60 is above the median of 50 across 619 interventional studies indexed under Macular Edema.

Browse Macular Edema studies →

Lead sponsor

The University of Hong Kong is the lead sponsor of 1,262 studies on the registry; 340 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • ProcedureEnd-Point-Management grid laser
  • Drugranibizumab
  • DrugBevacizumab
06

What researchers measure

Primary outcomes

  1. Difference in number of anti-VEGF required

    The number of injections of anti-VEGF required at the end of the 6 months period.

    Time frame: 6 months

Secondary outcomes

  1. Change in best corrected visual acuity

    The change in best corrected visual acuity among subjects in different groups at the end of the 6 months period when compared to baseline.

    Time frame: 6 months

  2. Central retinal thickness

    The change in central retinal thickness among subjects in different groups at the end of the 6 months period when compared to baseline.

    Time frame: 6 months

  3. Treatment related complications

    This will look at treatment related complications in terms of changes in intraocular pressure post-injection

    Time frame: 6 months

  4. Treatment related complications

    This will look at treatment related complications in terms of infection

    Time frame: 6 months

  5. Treatment related complications

    This will look at treatment related complications in terms of retinal detachment

    Time frame: 6 months

  6. Recurrence of macular edema

    Recurrence of macular edema during the 6 months period will be monitored.

    Time frame: 6 months

07

Study locations

1 site
  • The University of Hong Kong
    Hong Kong, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02462304
Lead sponsor
The University of Hong Kong
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 Hospital, Chungnam National University Hospital, Sun Cheon Hyang University, Kyunghee University, Yeungnam University Hospital, Korea University, National University Hospital, Singapore, Yamagata University
Responsible party
Dr. WONG Yat-hin Ian (Clinical Assistant Professor, The University of Hong Kong) — Principal investigator
First posted
Jun 4, 2015
Start date
Jun 2015
Primary completion
Jun 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
Apr 19, 2016

Study contacts

Ian Wong, FRCOphth
principal investigator · The University of Hong Kong

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.

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