NCT00370669

Brief Summary

to compare the effect of intravitreal bevacizumab alone or in combination with triamcinolone acetonide with laser photocoagulation on clinically significant macular edema (CSME)

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
150

participants targeted

Target at P25-P50 for phase_3

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
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2006

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2007

Completed
Last Updated

February 22, 2007

Status Verified

February 1, 2007

First QC Date

August 30, 2006

Last Update Submit

February 21, 2007

Conditions

Diabetic Macular Edema

Keywords

BevacizumabCSMEMPCTriamcinolone acetonide

Outcome Measures

Primary Outcomes (2)

  • visual acuity

  • central macular thickness

Secondary Outcomes (4)

  • Leakage in fluorescein angiography

  • intraocular pressure

  • cataract progression

  • anterior chamber reaction

Interventions

bevacizumabDRUG
triamcinolone acetonideDRUG

Eligibility Criteria

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

You may qualify if:

  • case with clear media IOP below 23 mm/Hg female after menopause at least for 12 months or had 2 contraceptive roots visual acuity between 20/50 to 20/320

You may not qualify if:

  • no PRP or N.d YAG laser in past 6 months no intraocular surgery in past 12 months
  • CVA in past 12 months blood sugar above 250
  • active infection in extraocular adnexa

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Masoud Soheilian

Tehran, Tehran Province, 16666, Iran

RECRUITING

Related Publications (2)

  • Soheilian M, Garfami KH, Ramezani A, Yaseri M, Peyman GA. Two-year results of a randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus laser in diabetic macular edema. Retina. 2012 Feb;32(2):314-21. doi: 10.1097/IAE.0b013e31822f55de.

    PMID: 22234244DERIVED

  • Soheilian M, Ramezani A, Obudi A, Bijanzadeh B, Salehipour M, Yaseri M, Ahmadieh H, Dehghan MH, Azarmina M, Moradian S, Peyman GA. Randomized trial of intravitreal bevacizumab alone or combined with triamcinolone versus macular photocoagulation in diabetic macular edema. Ophthalmology. 2009 Jun;116(6):1142-50. doi: 10.1016/j.ophtha.2009.01.011. Epub 2009 Apr 19.

    PMID: 19376585DERIVED

MeSH Terms

Interventions

BevacizumabTriamcinolone Acetonide

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Masoud Soheilian

    Ophthalmic Research Center of Shaheed Beheshti Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Masoud Soheilian, MD

CONTACT

+98 21 22585952labbafi@hotmail.com

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

September 1, 2006

Study Start

November 1, 2005

Study Completion

February 1, 2007

Last Updated

February 22, 2007

Record last verified: 2007-02

Locations

IR(1)