Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

The recruitment status of this study is unknown because the information has not been verified recently.

Verified February 2007 by Shaheed Beheshti Medical University. Recruitment status was Recruiting

First Received on August 30, 2006. Last Updated on February 21, 2007 History of Changes

Sponsor:	Shaheed Beheshti Medical University
Information provided by:	Shaheed Beheshti Medical University
ClinicalTrials.gov Identifier:	NCT00370669

Purpose

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

Condition	Intervention	Phase
Diabetic Macular Edema	Drug: bevacizumab Drug: triamcinolone acetonide	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Bevacizumab Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

Further study details as provided by Shaheed Beheshti Medical University:

Primary Outcome Measures:

visual acuity
central macular thickness

Secondary Outcome Measures:

Leakage in fluorescein angiography
intraocular pressure
cataract progression
anterior chamber reaction

Estimated Enrollment:	150
Study Start Date:	November 2005
Estimated Study Completion Date:	February 2007

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.

Eligibility

Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00370669

Contacts

Contact: Masoud Soheilian, MD

+98 21 22585952

labbafi@hotmail.com

Locations

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

Shaheed Beheshti Medical University

Investigators

Principal Investigator:

Masoud Soheilian

Ophthalmic Research Center of Shaheed Beheshti Medical University

More Information

No publications provided by Shaheed Beheshti Medical University

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

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. Epub 2009 Apr 19.

ClinicalTrials.gov Identifier:	NCT00370669 History of Changes
Other Study ID Numbers:	8411
Study First Received:	August 30, 2006
Last Updated:	February 21, 2007
Health Authority:	Iran: Ethics Committee

Keywords provided by Shaheed Beheshti Medical University:

Bevacizumab
CSME
MPC
Triamcinolone acetonide

Additional relevant MeSH terms:

Edema
Macular Edema
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone
Triamcinolone diacetate
Bevacizumab
Anti-Inflammatory Agents
Therapeutic Uses

Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Growth Inhibitors
Antineoplastic Agents

ClinicalTrials.gov processed this record on February 09, 2012