Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

Diabetic Macular Edema Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00370669
• Other study ID #: 8411
• Status: Recruiting
• Phase: Phase 3
• First received: August 30, 2006
• Last updated: February 21, 2007
• Start date: November 2005
• Est. completion date: February 2007

Study information

• Verified date: February 2007
• Source: hahid Beheshti University of Medical Sciences
• Contact: Masoud Soheilian, MD
• Phone: +98 21 22585952
• Email: labbafi[@]hotmail.com
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Macular Edema

Intervention

Drug:
• bevacizumab

• triamcinolone acetonide

Locations

Country	Name	City	State
Iran, Islamic Republic of	Masoud Soheilian	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
hahid Beheshti University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visual acuity
Primary	central macular thickness
Secondary	Leakage in fluorescein angiography
Secondary	intraocular pressure
Secondary	cataract progression
Secondary	anterior chamber reaction