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IRCT20200314046761N1 IRCT 2020-03-21 Esfahan University of Medical Sciences Effect of single dose suprachoroidal triamcinolone acetonide injection on diabetic macular edema. To evaluate the effect of single dose suprachoroidal triamcinolone acetonide injection combined with three monthly intravitreal injection of bevacizumab on center-involving diabetic macular edema in patients with non-proliferative diabetic retinopathy compared to the control group. 2019-09-23 anticipated 59 Complete https://irct.ir/trial/46494 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible eyes were randomly assigned into 2 group ( intervention, control) using random block permutation software, Blinding description: 1- At the onset, patients are completely informed about the trial and randomization process and they are blinded to the grouping. 2- The researcher cannot be blinded because he performs all the interventions himself. However, mean best corrected visual acuity changes as the primary outcome are measured by a blinded resident. Central macular thickness (CMT), central macular volume (CMV) etc. as the secondary outcomes are measured by automatic spectral domain optical coherence tomography (SD-OCT) by a trained blinded technician. 3- The statistical analyst is blinded to the grouping. 2-3 Center-involving diabetic macular edema. Intervention 1: Intervention group: Single dose suprachoroidal triamcinolone acetonide (4 mg / 0.1 cc) injection using custom made needle + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections for 3 consecutive months. Intervention 2: Control group: simulating suprachoroidal injection (sham injection: pressing the sclera with the same gauge needle without entering the sclera) in the first injection + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections for 3 consecutive months. Yes - There is a plan to make this available What will be shared: After the patients have been unrecognized, full data can be shared. When: The requests will be accepted at least 6 months after publishing the last results. To whom: Researchers in the field of ophthalmology Conditions: - Where to obtain: Mohammadeza Fazel How to obtain: Sending an email including the reason of request and personal curriculum vitae. Comments:
public Dr.Farhad Fazel, Dr.Mohammadreza Fazel
No 84, Asiab Alley, East Nazar Street
Isfahan Iran (Islamic Republic of) 8173655734 +98 31 3629 2656 mr.fazel90@gmail.com Esfahan University of Medical Sciences scientific Dr.Farhad Fazel, Dr.Mohammadreza Fazel
No 84, Asiab Alley, East Nazar Street
Isfahan Iran (Islamic Republic of) 8173655734 +98 31 3629 2656 mr.fazel90@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with non-proliferative diabetic retinopathy with center-involving diabetic macular edema with best corrected visual acuity ≤ 20/40. Patients have not received any interventions (Intravitreal injection, laser, intraocular surgery) 3 months prior to the recruitment. No history of deep vitrectomy. 18 years no limit Both Other comorbid conditions such as CNV, RVO, Glaucoma etc. Pregnancy Significant cataract E08.311 Diabetes mellitus due to underlying condition with unspecified diabetic retinopathy with macular edema. Treatment - Drugs Treatment - Drugs Intervention group: Single dose suprachoroidal triamcinolone acetonide (4 mg / 0.1 cc) injection using custom made needle + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections for 3 consecutive months Control group: simulating suprachoroidal injection (sham injection: pressing the sclera with the same gauge needle without entering the sclera) in the first injection + intravitreal bevacizumab (1.25 mg / 0.05 cc) injections for 3 consecutive months Mean change in best corrected visual acuity (BCVA). Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: 1- Snellen chart 2- Early Treatment Diabetic Retinopathy Study (ETDRS) letters. Mean changes in central macular thickness. Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: Spectral domain optical coherence tomography. Mean changes in central macular volume. Timepoint: Baseline (Day 0), a month after third intravitreal injection (Day 90-95). Method of measurement: Spectral domain optical coherence tomography. Mean changes in intraocular pressure. Timepoint: Baseline (Day 0), day 30, a month after third intravitreal injection (Day 90-95). Method of measurement: Applanation tonometry. Esfahan University of Medical Sciences Approved 2019-11-02 Ethics committe of Isfahan University of Medical Sciences (IR.MUI.REC). No 84, Asiab Alley, Esta Nazar Street. Isfahan Isfehan Iran (Islamic Republic of)