Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

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ClinicalTrials.gov Identifier: NCT00370669

Recruitment Status : Unknown

Verified February 2007 by Shahid Beheshti University of Medical Sciences.
Recruitment status was: Recruiting

First Posted : September 1, 2006

Last Update Posted : February 22, 2007

Sponsor:

Information provided by:

Shahid Beheshti University of Medical Sciences

Study Description

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)

Condition or disease	Intervention/treatment	Phase
Diabetic Macular Edema	Drug: bevacizumab Drug: triamcinolone acetonide	Phase 3

Detailed Description:

we entered 150 eyes into the study that recruitment of cases finished recently.Eligible eyes randomly assign to one of the study arms including intravitreal bevacizumzb, intravitreal bevacizumzb/triamcinolone and macular photocoagulation groups. Every patient needs at least 1 year followup. During this time BCVA, OCT, FA will be done for each patient and inaccording to interpretation of datas and fundus exam repeatation of injection will be done.

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	150 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Treatment
Study Start Date :	November 2005
Study Completion Date :	February 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

Drug Information available for: Bevacizumab

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

visual acuity
central macular thickness

Secondary Outcome Measures :

Leakage in fluorescein angiography
intraocular pressure
cataract progression
anterior chamber reaction

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Older Adult
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00370669

Contacts

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Contact: Masoud Soheilian, MD	+98 21 22585952	labbafi@hotmail.com

Locations

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Iran, Islamic Republic of
Masoud Soheilian	Recruiting
Tehran, Iran, Islamic Republic of, 16666
Contact: Masoud Soheilian, MD +98 21 22585952 labbafi@hotmail.com

Sponsors and Collaborators

Shahid Beheshti University of Medical Sciences

Investigators

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Principal Investigator:	Masoud Soheilian	Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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ClinicalTrials.gov Identifier:	NCT00370669
Other Study ID Numbers:	8411
First Posted:	September 1, 2006 Key Record Dates
Last Update Posted:	February 22, 2007
Last Verified:	February 2007

Keywords provided by Shahid Beheshti University of Medical Sciences:


Bevacizumab CSME MPC Triamcinolone acetonide

Additional relevant MeSH terms:

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Macular Edema Edema Macular Degeneration Retinal Degeneration Retinal Diseases Eye Diseases Triamcinolone Triamcinolone Acetonide Triamcinolone hexacetonide Bevacizumab Triamcinolone diacetate Antineoplastic Agents, Immunological Antineoplastic Agents	Angiogenesis Inhibitors Angiogenesis Modulating Agents Growth Substances Physiological Effects of Drugs Growth Inhibitors Anti-Inflammatory Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Immunosuppressive Agents Immunologic Factors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

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