Effect of Intravitreal Bevacizumab on Clinically Significant Macular Edema

Condition(s) targeted: Diabetic Macular Edema

Intervention: bevacizumab (Drug); triamcinolone acetonide (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Shaheed Beheshti Medical University

Official(s) and/or principal investigator(s):
Masoud Soheilian, Principal Investigator, Affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University

Overall contact:
Masoud Soheilian, MD, Phone: +98 21 22585952, Email: labbafi@hotmail.com

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

Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome:

visual acuity

central macular thickness

Secondary outcome:

Leakage in fluorescein angiography

intraocular pressure

cataract progression

anterior chamber reaction

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.

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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

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

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

Starting date: November 2005
Ending date: February 2007
Last updated: February 21, 2007