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IRCT20201120049450N7 IRCT 2026-07-13 Shiraz University of Medical Sciences : Combined anti-VEGF and low-dose triamcinolone intravitreal injections versus anti-VEGF alone for treatment ofmacular edema due to central retinal vein occlusion : Combined anti-VEGF and low-dose triamcinolone intravitreal injections versus anti-VEGF alone for treatment ofmacular edema due to central retinal vein occlusion: A Randomized clinical trial 2026-04-05 anticipated 64 Complete https://irct.ir/trial/83073 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: "Patients who meet all eligibility and registration criteria will be randomized to the treatment groups using simple randomization based on a table of random numbers, with an allocation ratio of 1:1. Randomization will be performed only after a participant has been confirmed as eligible and enrolled in the study. To minimize selection and allocation bias, the randomization sequence will be implemented by an assistant who is not involved in patient recruitment, clinical management, treatment administration, or outcome assessment. The treating investigators will not participate in the allocation process. This procedure is intended to ensure that group assignment remains unbiased and independent of clinical decision-making.", Blinding description: "This study will employ a double-blind design. Blinding will extend to all individuals involved in the trial to minimize potential biases that could arise from knowledge of treatment allocation. Specifically: Participants: Will be unaware of which treatment arm they have been assigned to. The Principal Investigator: Will be blinded to the treatment assignments throughout the study duration. Healthcare Providers: All healthcare professionals directly involved in the care of participants during the trial, including those administering treatments or managing participant well-being, will be blinded. Data Collectors: Individuals responsible for collecting data at any point during the trial will be unaware of the participants’ treatment allocation. Outcome Assessors: Personnel responsible for assessing participant outcomes, both before and after the intervention period, will be blinded to treatment assignments.". 2-3 retinal disorders. Intervention 1: Intervention group: intravitreal injection of combined bevacizumab and triamcinolone. Participants in this group will receive intravitreal injections of both an anti-vascular endothelial growth factor (anti-VEGF) agent and a low-dose corticosteroid (Triamcinolone Acetonide). Intervention 2: Control group: intravitreal injection of bevacizumab. Participants in this group will receive intravitreal injections of an anti-VEGF agent alone. 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 macular edema due to central retinal vein occlusion: 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@sums.ac.ir 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) Participants Patients with center-involved macular edema due to CRVO baseline BCVA between ۲۰/۴۰۰ and ۲۰/۴۰ CSFT of more than ۳۲۰ microns on Heidelberg Spectralis SD-OCT machine 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 comprised monocular patients presence of any ocular neovascularization or ONH shunts pathologic myopia glaucoma any significant media opacity concomitant retinal disorder (such as aging macular degeneration, diabetic retinopathy, vitreomacular traction, epiretinal membrane, etc.) previous intraocular surgery (other than uneventful cataract surgery) noncompliance with any of the therapeutic or diagnostic interventions H35 Other retinal disorders Treatment - Surgery Treatment - Surgery Intervention group: intravitreal injection of combined bevacizumab and triamcinolone. Participants in this group will receive intravitreal injections of both an anti-vascular endothelial growth factor (anti-VEGF) agent and a low-dose corticosteroid (Triamcinolone Acetonide). Control group: intravitreal injection of bevacizumab. Participants in this group will receive intravitreal injections of an anti-VEGF agent alone. 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 2025-12-10 ethics committee at Shiraz university of Medical Sciences Khalili street Shiraz Fars Iran (Islamic Republic of)