Combined anti-Vascular Endothelial Growth Factor (VEGF) and low-dose triamcinolone intravitreal injections versus anti-VEGF alone for treatment of diabetic macular edema

Combined anti-Vascular Endothelial Growth Factor (VEGF) and low-dose triamcinolone intravitreal injections versus anti-VEGF alone for treatment of diabetic macular edema: A Randomized clinical trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20201120049450N6

Enrollment

Registered

2025-04-20

Start date

2025-04-05

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

retinal disorder. H35

Interventions

Intervention 1: Control group: intravitreal injection of bevacizumab. Intervention 2: Intervention group: intravitreal injection of bevacizumab and triamcinolone.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with center-involved macular edema due to DM, baseline BCVA between ??/??? and ??/??, CSFT of more than ??? microns on Heidelberg Spectralis SD-OCT machine .Eyes with previous treatment were allowed to be enrolled if they had intravitreal anti-VEGF or corticosteroids for at least two and four months before

Exclusion criteria

Exclusion criteria: monocular patients, presence of any ocular neovascularization or ONH shunts, pathologic myopia, glaucoma, any significant media opacity or concomitant retinal disorder (such as aging macular degeneration, retinal vein occlusion, vitreomacular traction, epiretinal membrane, etc.), previous intraocular surgery (other than uneventful cataract surgery), noncompliance with any of the therapeutic or diagnostic interventions

Design outcomes

Primary

Measure	Time frame
BCVA (best corrected visual acuity). Timepoint: one month after injection. Method of measurement: According to refractive errors acuited by auto spectacle with correcting lenses examined to achieve best corrected vision by snellen chart.;IOP(Intraocular pressure). Timepoint: one day and one month after injection. Method of measurement: Tonometery is the method of measurement which is performed by many different method in our study it is constructed by airpuff.;Cataract formation. Timepoint: one month after injection. Method of measurement: LOCS II grading system.;CSFT( central subfield foveal thickness). Timepoint: one month after injection. Method of measurement: Macular optical coherence tomography macular volume demographic thickness map.	—

Measure

Time frame

BCVA (best corrected visual acuity). Timepoint: one month after injection. Method of measurement: According to refractive errors acuited by auto spectacle with correcting lenses examined to achieve best corrected vision by snellen chart.;IOP(Intraocular pressure). Timepoint: one day and one month after injection. Method of measurement: Tonometery is the method of measurement which is performed by many different method in our study it is constructed by airpuff.;Cataract formation. Timepoint: one month after injection. Method of measurement: LOCS II grading system.;CSFT( central subfield foveal thickness). Timepoint: one month after injection. Method of measurement: Macular optical coherence tomography macular volume demographic thickness map.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactEhsan namvar

Shiraz University of Medical Sciences

namvar.e@gmail.com+98 71 3629 1470

Outcome results

None listed

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