Intravitreal Triamcinolone Acetonide Versus Intravitreal Bevacizumab for Refractory Diabetic Macular Edema (IBEME Study)

University of Sao Paulo

Status and phase

Unknown

Phase 1

Conditions

Diabetic Macular Edema

Treatments

Procedure: Intravitreal Injection of 1,5 mg of bevacizumab

Procedure: Intravitreal injection of 4 mg of Triamcinolone acetonide

Study type

Interventional

Funder types

Other

Identifiers

NCT00468351

154342005

Details and patient eligibility

About

Intravitreal triamcinolone has been effective for central macular thickness reduction and concomitant visual acuity improvement in patients with diabetic macular edema (DME). VEGF is a very effective inducer of permeability, being 50.000 times more potent than histamine, and may exert its effect on retinal vascular permeability by altering tight-junctions proteins, such as occluding and VE-cadherin. Based on these principles, there is a rationale for anti-VEGF agents treatment of increased retinal capillary permeability conditions, such as diabetic macular edema. Therefore, we conducted a randomized, prospective study to compare the efficacy and safety of intravitreal triamcinolone acetonide and intravitreal bevacizumab injection for refractory diffuse DME.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Refractory diffuse DME (defined herein as clinically significant DME [by biomicroscopic evaluation] unresponsive to focal laser photocoagulation [performed at least 3 months before evaluation] and generalized breakdown of the inner blood-retina barrier with diffuse fluorescein leakage involving the foveal center and most of the macular area on fluorescein angiography),
Snellen logarithm of minimum angle of resolution (LogMAR) BCVA equivalent of 20/40 or worse, and 3) central macular thickness (CMT) greater than 300µm on optical coherence tomography (OCT)

Exclusion criteria

Aphakic or pseudophakic eyes,
Glycosylated hemoglobin (Hb A1C) rate above 10%,
History of glaucoma or ocular hypertension,
Loss of vision as a result of other causes,
Systemic corticoid therapy,.
History of thromboembolic event (including myocardial infarction or cerebral vascular accident);
Major surgery within the prior 6 months or planned within the next 28 days;
Uncontrolled hypertension (according to guidelines of the seventh report of the joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC-7]);16
Known coagulation abnormalities or current use of anticoagulative medication other than aspirin;
Severe systemic disease; or
Any condition affecting follow-up or documentation