NCT02462304

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2015

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 4, 2015

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

April 19, 2016

Status Verified

April 1, 2016

Enrollment Period

2 years

First QC Date

March 23, 2015

Last Update Submit

April 17, 2016

Conditions

Diabetic Macula Edema

Keywords

Diabetic Macula EdemaEnd-Point-Managementranibizumabbevacizumab

Outcome Measures

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.

    6 months

Secondary Outcomes (6)

  • Change in best corrected visual acuity

    6 months

  • Central retinal thickness

    6 months

  • Treatment related complications

    6 months

  • Treatment related complications

    6 months

  • Treatment related complications

    6 months

  • +1 more secondary outcomes

Study Arms (2)

Combination Anti-VEGF and EPM laser

EXPERIMENTAL

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

Procedure: End-Point-Management grid laserDrug: ranibizumabDrug: Bevacizumab

Anti-VEGF monotherapy

ACTIVE COMPARATOR

Subjects will receive anti-VEGF injections monotherapy.

Drug: ranibizumabDrug: Bevacizumab

Interventions

End-Point-Management grid laserPROCEDURE
Combination Anti-VEGF and EPM laser
ranibizumabDRUG
Anti-VEGF monotherapyCombination Anti-VEGF and EPM laser
BevacizumabDRUG
Anti-VEGF monotherapyCombination Anti-VEGF and EPM laser

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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).
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Hong Kong

Hong Kong, China

Location

MeSH Terms

Interventions

RanibizumabBevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Ian Wong, FRCOphth

    The University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

March 23, 2015

First Posted

June 4, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

April 19, 2016

Record last verified: 2016-04

Locations

CN(1)