]>
IRCT20201120049450N6 IRCT 2025-04-20 Shiraz University of Medical Sciences 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 2025-04-05 anticipated 64 Complete https://irct.ir/trial/79771 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: We use simple randomization using table of random numbers. The treatment group of each patient will be determined after passing the registration criteria. Randomization will be performed by an assistant who had no role in treating the patients, Blinding description: this study will be double blinded. participants, principle investigator, healthcare providers who care for participants during the trial, data collectors, outcome assessors before and after treatment will be blinded. 2-3 retinal disorder. Intervention 1: Control group: intravitreal injection of bevacizumab. Intervention 2: Intervention group: intravitreal injection of bevacizumab and triamcinolone. Yes - There is a plan to make this available What will be shared: Combined anti-VEGF and low-dose triamcinolone intravitreal injections versus anti-VEGF alone for treatment of diabetic macular edema :A Randomized clinical trial When: 6 months after publication To whom: people working in academic institutions Conditions: references or meta-analysis Where to obtain: namvar.e@gmail.com How to obtain: email to responsible person Comments:
public Ehsan namvar
valiasr street
shiraz Iran (Islamic Republic of) 7193636981 +98 71 3629 1470 namvar.e@gmail.com Shiraz University of Medical Sciences scientific Ehsan namvar
valiasr street
shiraz Iran (Islamic Republic of) 7193636981 +98 71 3629 1470 namvar.e@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) Patients with center-involved macular edema due to DM, baseline BCVA between ۲۰/۴۰۰ and ۲۰/۴۰, CSFT of more than ۳۲۰ 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 18 years no limit Both 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 other reti H35 Treatment - Surgery Treatment - Surgery Control group: intravitreal injection of bevacizumab Intervention group: intravitreal injection of bevacizumab and triamcinolone 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. Shiraz University of Medical Sciences Approved 2025-03-11 ethics committee at Shiraz university of Medical Sciences Khalili street Shiraz Fars Iran (Islamic Republic of)