effect of Bevacizumab alone or in combination with 1 mg Triamcinolone for treatment of diabetic retina swelling

Intravitreal Bevacizumab alone or in combination with 1 mg Triamcinolone in diabetic macular edema

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2014080818733N1

Enrollment

Registered

2015-03-16

Start date

2014-10-23

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

Diabetic Macular Edema. Diabetic retinopathy

Interventions

Intervention 1: For the IVB group, 0.05 ml (1.25 mg) of bevacizumab was injected intravitreally with a 27-gauge needle through the supratemporal quadrant. Intervention 2: For the IVB+IVT group, 0.05 m

Treatment - Drugs

For the IVB group, 0.05 ml (1.25 mg) of bevacizumab was injected intravitreally with a 27-gauge needle through the supratemporal quadrant.

For the IVB+IVT group, 0.05 ml (1.25 mg) of Bevacizumab was injected intravitreally with a 27-gauge needle through the infratemporal quadrant in combination with 0.025 ml of Triamcinolone(1mg).

Eligibility

Sex/Gender

All

Age

20 Years to 85 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: bilateral macular edema with foveal involvement; Visual acuity between 20/40-20/400; Age more than 20; HbA1c more less than 10; Blood pressure less than 160/100. Exclusion criteria: previous panretinal or focal laser photocoagulation; prior vitreoretinalr surgery or injection; unilateral cataract surgery; history of glaucoma or ocular hypertension; VA worse than 20/400; proliferative diabetic retinopathy; significant media opacity; Monocularity; Central macular thickness>320; pregnancy; serum creatinine>3 mg/dl; other retinal diseases; unilateral cataract surgery; Cataract surgery during last 3 months; macular ischemia (Foveal avascular zone>100); uncontrolled blood pressure or diabetes with medication; previous corticostroid consumption during last 3 months; HbA1c>10

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Visual acuity. Timepoint: At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection. Method of measurement: Snellen chart.;Macular Thickness. Timepoint: At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection. Method of measurement: Optical coherencetomography( Heidelberg spectoralis Sd)( roct/germany)OCT.	—

Measure

Time frame

Visual acuity. Timepoint: At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection. Method of measurement: Snellen chart.;Macular Thickness. Timepoint: At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection. Method of measurement: Optical coherencetomography( Heidelberg spectoralis Sd)( roct/germany)OCT.

—

Secondary

Measure	Time frame
Lens Cataract. Timepoint: Base line and each 2 months after injection. Method of measurement: Slit-lamp Examination.;Intraocular Pressure. Timepoint: At baseline before injection and then 2 weeks, 4 weeks, 6 weeks, 8 weeks, 12 weeks, 6 months,12 months and 24 months after first injection. Method of measurement: Goldman tonometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactHamid Riazi Esfahani

Eye research center, Farabi Eye Hospital

hamidriazi@gmail.com+98 21 5542 1002

Outcome results

None listed

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