Comparison of the effect of intravitreal injection of bevacizumab (Stevenet) alone with intravitreal injection of bevacizumab and triamcinolone in the treatment of diabetic macular edema with a thickness greater than 500 microns in patients

Comparison of the effect of intravitreal injection of Bevacizumab (Stevenet) alone with intravitreal injection of Bevacizumab and Triamcinolone in the treatment of diabetic macular edema with a thickness greater than 500 microns in patients referred to Shafa Hospital.

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

IRCT

Registry ID

IRCT20211130053229N1

Enrollment

Registered

2023-03-05

Start date

2023-03-06

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic macular edema. Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema

Interventions

Intervention 1: Intervention group: In the first intervention group, bevacizumab 0.05 ml (1.25 mg) 3 doses will be randomly injected monthly (Avastin

Genen-tech, Inc., South San Francisco, CA (made for F. Hoffmann) -La Roche, Ltd., Basel, Switzerland)-off label drug), in both groups, the injection is done in one eye (the eye with a macular thicknes

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with clinically significant DME according to ETDRS criteria Patients with clinically significant DME based on criteria of central thickness greater than 500 microns

Exclusion criteria

Exclusion criteria: History of previous DME treatment (focal or panretinal laser coagulation or IVB or IVT) Eye surgery Glaucoma or ocular hypertension monocular vision pregnancy Significant media opacity CMT<500 The patient's absence in follow-up in the following weeks

Design outcomes

Primary

Measure	Time frame
BCVA change based on LogMAR chart. Timepoint: BCVA measurement at baseline and at week 12. Method of measurement: Based on Snellen chart.	—

Secondary

Measure	Time frame
Changes in central macular thickness (CMT). Timepoint: CMT changes at weeks 4, 8, 12. Method of measurement: Optical coherence tomography.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactKerman University of Medical Sciences

Kerman University of Medical Sciences

maysam.shekofteh@yahoo.com+98 34 3211 5780

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026