NCT00874744

Brief Summary

The purpose of this study is to compare a single intravitreal injection of 4.0 mg of triamcinolone acetonide and 1.25 mg of bevacizumab for the treatment of diabetic macular edema.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_2

Status
completed

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

Study Start

First participant enrolled

March 1, 2008

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
Last Updated

April 2, 2009

Status Verified

March 1, 2009

Enrollment Period

6 months

First QC Date

March 31, 2009

Last Update Submit

March 31, 2009

Conditions

Diabetic Macular Edema

Keywords

Diabetic macular edemaintravitreal injectionPharmacological treatment

Outcome Measures

Primary Outcomes (1)

  • Comparison between the efficacy of a single intravitreal injection of 4.0mg of triamcinolone acetonide or 1.25mg of bevacizumab in the treatment of diabetic macular edema

    6 months

Secondary Outcomes (2)

  • To compare Visual Acuity between the same drug in Initial visit, 4, 12 ans 24 weeks and Visual Acuity between two group of eyes treated with different drugs.

    6 months

  • To compare Intraocular Pressure between the same drug in Initial visit, 4, 12 ans 24 weeks and Intraocular Pressure between two group of eyes treated with different drugs.

    6 months

Study Arms (2)

bevacizumab

EXPERIMENTAL
Drug: Bevacizumab

Triamcinolone

EXPERIMENTAL
Drug: Triamcinolone acetonide

Interventions

BevacizumabDRUG

1.25mg bevacizumab (0.05ml)

Also known as: 1.Bevacizumab, 2.Avastin
bevacizumab
Triamcinolone acetonideDRUG

4.0 mg Triamcinolone acetonide injection

Also known as: 1. Theracort, 2. Kenalog
Triamcinolone

Eligibility Criteria

Age40 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetic macular edema with central foveal measurement over 300 micrometers

You may not qualify if:

  • Glaucoma
  • Vitreoretinal surgery
  • Unilateral cataract surgery
  • Uncontrolled Glycosylated Hemoglobin
  • Previous Intraocular Injection
  • Macular ischemia at Fluorescein Angiography
  • Cataract precluding fundus examination
  • Active Proliferative Diabetic Retinopathy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

BevacizumabTriamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulinsTriamcinolonePregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • David LC Isaac, MD, PhD

    Universidade Federal de Goias

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

March 1, 2008

Primary Completion

September 1, 2008

Study Completion

October 1, 2008

Last Updated

April 2, 2009

Record last verified: 2009-03