NCT02310295

Brief Summary

Purpose: To compare the effects of macular photocoagulation with or without intravitreal bevacizumab (IVB) or triamcinolone (IVTA) for the treatment of diabetic macular edema (DME). Casuistic and Methods: 58 eyes of 44 patients with diffuse DME were randomized to receive either IVB + focal/grid laser (IVB-Laser, n=19), IVTA + focal/grid laser (IVTA-Laser, n=16) or focal/grid laser alone (Laser, n=23). Ophthalmic evaluation, including best-corrected visual acuity (BCVA), intraocular pressure (IOP) and central macular thickness (CMT) were performed at baseline and monthly for 12 months.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 2, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 8, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

2.9 years

First QC Date

December 2, 2014

Last Update Submit

December 5, 2014

Conditions

Diabetic Macular Edema

Keywords

Diabetic retinopathyMacular edemaAnti-VEGFTriamcinolone

Outcome Measures

Primary Outcomes (2)

  • Central subfield macular thickness

    retinal thickness measured with optical coherence tomography

    12 months

  • Visual acuity

    Best corrected visual acuity

    12 months

Study Arms (3)

IVB-Laser

ACTIVE COMPARATOR

Intravitreal Bevacizumab combined with focal laser therapy

Device: LaserDrug: Bevacizumab

IVTA-Laser

ACTIVE COMPARATOR

Intravitreal Triamcinolone combined with focal laser therapy

Device: LaserDrug: Triamcinolone Acetonide

Laser

ACTIVE COMPARATOR

focal laser therapy

Device: Laser

Interventions

LaserDEVICE

focal macular laser therapy

IVB-LaserIVTA-LaserLaser
BevacizumabDRUG

Intravitreal injection of Bevacizumab

IVB-Laser
Triamcinolone AcetonideDRUG

Intravitreal injection of Triamcinolone Acetonide

IVTA-Laser

Eligibility Criteria

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

You may qualify if:

  • clinically significant diabetic macular edema (DME) with diffuse leakage involving the center of the fovea, with DME greater than 275 microns in OCT examination
  • BCVA between 0.3 LogMAR (logarithm of smaller angle of visual resolution) (20/40) and 1.6 LogMAR (20/800)
  • signed of inform Consent.

You may not qualify if:

  • HbA1c levels greater than 10%
  • thromboembolic event history (including myocardial infarction and stroke)
  • vitreo-macular traction on OCT
  • coagulation disorders
  • macular ischemia on fluorescein angiography examination
  • proliferative diabetic retinopathy that required treatment
  • eye surgery
  • history of ocular hypertension or glaucoma
  • any ocular pathology which in the opinion of the investigator, could macular edema or change the visual acuity during the study period (for example, retinal vascular occlusion, uveitis or other inflammatory eye disease, neovascular glaucoma)
  • systemic corticosteroid therapy
  • any conditions that could affect the documentation
  • any previous treatment for diabetic macular edema.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic RetinopathyMacular Edema

Interventions

LasersBevacizumabTriamcinolone Acetonide

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesMacular DegenerationRetinal Degeneration

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and SuppliesAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

December 2, 2014

First Posted

December 8, 2014

Study Start

January 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

December 8, 2014

Record last verified: 2014-12