NCT00370422

Brief Summary

The purpose of this study is to compare the efficacy and safety of intravitreal injection of bevacizumab alone versus bevacizumab combined with triamcinolone for treatment of refractory diabetic macular edema.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Nov 2005

Shorter than P25 for phase_3

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

Study Start

First participant enrolled

November 1, 2005

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 31, 2006

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
Last Updated

March 13, 2007

Status Verified

October 1, 2005

First QC Date

August 30, 2006

Last Update Submit

March 12, 2007

Conditions

Diabetic Macular Edema

Keywords

Cystoid macular edemaDiabetic macular edemaHard exudatesIntravitreal bevacizumabIntravitreal triamcinoloneMacular thickness

Outcome Measures

Primary Outcomes (2)

  • Visual acuity

  • Central macular thickness

Secondary Outcomes (3)

  • Cataract progression

  • Intraocular pressure

  • Anterior chamber reaction

Interventions

Triamcinolone, BevacizumabDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cases with clinically significant macular edema (CSME) with persistent retinal thickening after initial or supplemental macular photocoagulation

You may not qualify if:

  • Monocularity,
  • History of vitrectomy,
  • Glaucoma or ocular hypertension,
  • Significant media opacity,
  • Existence of traction on the macula

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hamid Ahmadieh, MD

Tehran, Tehran Province, 16666, Iran

Location

Related Publications (1)

  • Ahmadieh H, Ramezani A, Shoeibi N, Bijanzadeh B, Tabatabaei A, Azarmina M, Soheilian M, Keshavarzi G, Mohebbi MR. Intravitreal bevacizumab with or without triamcinolone for refractory diabetic macular edema; a placebo-controlled, randomized clinical trial. Graefes Arch Clin Exp Ophthalmol. 2008 Apr;246(4):483-9. doi: 10.1007/s00417-007-0688-0. Epub 2007 Oct 5.

    PMID: 17917738DERIVED

MeSH Terms

Conditions

Macular Edema

Interventions

TriamcinoloneBevacizumab

Condition Hierarchy (Ancestors)

Macular DegenerationRetinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

PregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Hamid Ahmadieh, MD

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 30, 2006

First Posted

August 31, 2006

Study Start

November 1, 2005

Study Completion

September 1, 2006

Last Updated

March 13, 2007

Record last verified: 2005-10

Locations

IR(1)